Job Archives

Regular
21 Cotters Lane/16 Elkins Road East Brunswick
Posted 1 month ago

Key Job Requirements

Confidential Document

Position Title: Maintenance Engineer 

Functional Area and Department: Maintenance

Reports to (Title): Maintenance Manager 

Date: Aug 08th, 2023

Location: 21 Cotters/16 Elkins

Classification: Non-Exempt


Job Summary:

The Maintenance Engineer plays a critical role in ensuring the smooth operation and maintenance of all equipment, machinery, and facilities within the pharmaceutical manufacturing plant. This role requires a strong understanding of mechanical, electrical, and automation systems and a deep knowledge of pharmaceutical manufacturing processes and regulatory requirements. The Maintenance Engineer collaborates with cross-functional teams to maintain equipment reliability, optimize performance, and uphold safety and quality standards.

Reporting Relationships                                

  • This position has direct reports.

Essential Functions:

  • Equipment Maintenance and Repair:
    • Conduct routine inspections, preventive maintenance, and repairs on pharmaceutical manufacturing equipment, including but not limited to mixing machines, compression machines, encapsulation machines, coating machines, and packaging machines.
    • Troubleshoot and diagnose equipment issues, perform root cause analysis, and implement effective solutions to minimize downtime. Respond promptly to equipment breakdowns and emergencies, working with urgency to restore operations while adhering to safety protocols.
    • Conduct routine, periodic, or special inspections to determine repair and maintenance work necessary to prevent breakdowns of facilities' machinery and utility equipment.
    • Collect quotations from vendors and create purchase requisitions for spare and repair parts.  Maintain inventory of parts required for preventative maintenance.
    • Coordinate with suppliers and vendors for spare parts procurement and ensure timely availability of critical components.
  • Documentation and Compliance:
    • Maintain accurate records of maintenance activities, including work orders, equipment history, and maintenance schedules.
    • Write SOP, protocols, and maintenance reports for manufacturing and utility equipment.
    • Authoring equipment specifications, user and functional requirements specifications, and necessary FAT.
    • Ensure compliance with regulatory guidelines and company SOPs (Standard Operating Procedures) for maintenance and engineering practices.
  • Continuous Improvement:
    • Identify opportunities for process improvement, reliability enhancement, and cost reduction in collaboration with the engineering and production teams.
    • Implement and participate in continuous improvement initiatives, including lean manufacturing and Six Sigma projects.
  • Team Collaboration:
    • Collaborate with cross-functional teams, including production, and quality control, to align maintenance activities with production goals and quality standards.
    • Provide technical support and training to operators and technicians on proper equipment operation and maintenance.
  • Safety and Compliance:
    • Adhere to and promote a strong safety culture by following all safety procedures and protocols.
    • Ensure that maintenance activities are conducted in compliance with environmental, health, and safety regulations.
  • Assist in commissioning or qualification activities of site equipment, building, and utility systems.
  • Set up and operate all tools and equipment necessary to perform assigned work
  • Assign work and resolve routine problems within the Maintenance Department.
  • Review structural blueprints for new projects.  Provide suggestions for change.
  • All other job-related duties.

Specialized Skills and Knowledge:                 

  • Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or a related field. Master's degree is a plus.
  • Minimum 5 years of experience repairing and maintaining pharmaceutical manufacturing and packaging equipment (oral solid dosage experience preferred).
  • Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements (cGMP, FDA guidelines).
  • Knowledge of Utility systems and HVAC systems.
  • Proficiency in troubleshooting and repairing mechanical, electrical, and automation systems.

Key Competencies:

  1. Strong organizational and demonstrated leadership skills
  2. Excellent verbal and written communication skills
  3. Speed/Action/Simplicity/Initiative
  4. Excellent problem-solving skills and ability to work under pressure.
  5. Strong collaboration skills to work effectively across teams and with stakeholders.

Physical Demands/Factors:

While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 55 pounds.  Specific vision abilities required by this job include close vision, distance vision, and color vision.  

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.


Job Features

Job CategoryMaintenance

Key Job Requirements Confidential Document Position Title: Maintenance Engineer  Functional Area and Department: Maintenance Reports to (Title): Maintenance Manager  Date: Aug 08th, 2023 Loc...

Regular
21 Cotters Lane/16 Elkins Road East Brunswick
Posted 1 month ago

Key Job Requirements

Confidential Document

Position Title: Maintenance Engineer 

Functional Area and Department: Maintenance

Reports to (Title): Maintenance Manager 

Date: Aug 08th, 2023

Location: 21 Cotters/16 Elkins

Classification: Non-Exempt


Job Summary:

The Maintenance Engineer plays a critical role in ensuring the smooth operation and maintenance of all equipment, machinery, and facilities within the pharmaceutical manufacturing plant. This role requires a strong understanding of mechanical, electrical, and automation systems and a deep knowledge of pharmaceutical manufacturing processes and regulatory requirements. The Maintenance Engineer collaborates with cross-functional teams to maintain equipment reliability, optimize performance, and uphold safety and quality standards.

Reporting Relationships                                

  • This position has direct reports.

Essential Functions:

  • Equipment Maintenance and Repair:
    • Conduct routine inspections, preventive maintenance, and repairs on pharmaceutical manufacturing equipment, including but not limited to mixing machines, compression machines, encapsulation machines, coating machines, and packaging machines.
    • Troubleshoot and diagnose equipment issues, perform root cause analysis, and implement effective solutions to minimize downtime. Respond promptly to equipment breakdowns and emergencies, working with urgency to restore operations while adhering to safety protocols.
    • Conduct routine, periodic, or special inspections to determine repair and maintenance work necessary to prevent breakdowns of facilities' machinery and utility equipment.
    • Collect quotations from vendors and create purchase requisitions for spare and repair parts.  Maintain inventory of parts required for preventative maintenance.
    • Coordinate with suppliers and vendors for spare parts procurement and ensure timely availability of critical components.
  • Documentation and Compliance:
    • Maintain accurate records of maintenance activities, including work orders, equipment history, and maintenance schedules.
    • Write SOP, protocols, and maintenance reports for manufacturing and utility equipment.
    • Authoring equipment specifications, user and functional requirements specifications, and necessary FAT.
    • Ensure compliance with regulatory guidelines and company SOPs (Standard Operating Procedures) for maintenance and engineering practices.
  • Continuous Improvement:
    • Identify opportunities for process improvement, reliability enhancement, and cost reduction in collaboration with the engineering and production teams.
    • Implement and participate in continuous improvement initiatives, including lean manufacturing and Six Sigma projects.
  • Team Collaboration:
    • Collaborate with cross-functional teams, including production, and quality control, to align maintenance activities with production goals and quality standards.
    • Provide technical support and training to operators and technicians on proper equipment operation and maintenance.
  • Safety and Compliance:
    • Adhere to and promote a strong safety culture by following all safety procedures and protocols.
    • Ensure that maintenance activities are conducted in compliance with environmental, health, and safety regulations.
  • Assist in commissioning or qualification activities of site equipment, building, and utility systems.
  • Set up and operate all tools and equipment necessary to perform assigned work
  • Assign work and resolve routine problems within the Maintenance Department.
  • Review structural blueprints for new projects.  Provide suggestions for change.
  • All other job-related duties.

Specialized Skills and Knowledge:                 

  • Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or a related field. Master's degree is a plus.
  • Minimum 5 years of experience repairing and maintaining pharmaceutical manufacturing and packaging equipment (oral solid dosage experience preferred).
  • Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements (cGMP, FDA guidelines).
  • Knowledge of Utility systems and HVAC systems.
  • Proficiency in troubleshooting and repairing mechanical, electrical, and automation systems.

Key Competencies:

  1. Strong organizational and demonstrated leadership skills
  2. Excellent verbal and written communication skills
  3. Speed/Action/Simplicity/Initiative
  4. Excellent problem-solving skills and ability to work under pressure.
  5. Strong collaboration skills to work effectively across teams and with stakeholders.

Physical Demands/Factors:

While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 55 pounds.  Specific vision abilities required by this job include close vision, distance vision, and color vision.  

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.


Job Features

Job CategoryMaintenance

Key Job Requirements Confidential Document Position Title: Maintenance Engineer  Functional Area and Department: Maintenance Reports to (Title): Maintenance Manager  Date: Aug 08th, 2023 Loc...

Regular
21 Cotters Lane/16 Elkins Road East Brunswick
Posted 1 month ago

Key Job Requirements

Confidential Document

Position Title:  Site Management Technician  

Functional Area and Department: Maintenance

Reports to (Title):  Maintenance Engineer

Date:

Location: 21 Cotters/16 Elkins

Classification: Non-Exempt


Job Summary:

The Site Management Technician is critical to maintaining building facilities and utility equipment in proper operation by troubleshooting breakdowns and performing necessary repairs.

Reporting Relationships                                

  • This position has direct reports.

Essential Functions:

  • Perform repairs of building facilities (patch/paint, plumbing repair, electrical repair, etc.).
  • Provide emergency/unscheduled repairs of building facilities and utility equipment during.
  • Assist Engineers to perform mechanical, electrical, pneumatic and hydraulic troubleshooting and repair of packaging and production equipment.
  • Make routine, periodic, or special inspections to determine repair and maintenance work necessary to prevent breakdowns of facilities, machinery, and equipment.
  • Cleaning of utility equipment/areas.
  • Servicing & cleaning of dust collection units and the solids separation pit.
  • Maintain pest-free facilities.
  • Snow removal.
  • Drive and load/unload truck.
  • Adhere to all safety and cGMP standards and guidelines, and report unsafe conditions, near misses, and/or injuries in a timely manner.

Specialized Skills and Knowledge:                 

  • High School Diploma or GED equivalent.
  • Perform work in more than one of the maintenance trades: carpentry, plumbing, painting, machine and equipment repair, electrical and forklift operation.
  • Moderate Functional Knowledge of Maintenance Trades

Key Competencies:

  1. Technical Knowledge
  2. Functional Knowledge
  3. Speed/Action/Simplicity/Initiative

Physical Demands/Factors:

While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and/or move up to 55 pounds. The employee is required to be able to move heavy equipment/parts by physical and/or mechanical means.  Specific vision abilities required by this job include close vision, distance vision, and color vision.

All roles: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.


Job Features

Job CategoryMaintenance

Key Job Requirements Confidential Document Position Title:  Site Management Technician   Functional Area and Department: Maintenance Reports to (Title):  Maintenance Engineer Date: Loca...

Regular
21 Cotters Lane, East Brunswick
Posted 1 month ago

Job Summary:

Packaging Operator is an entry-level position in the packaging department. Packing Operator is responsible for setup, cleanup, and safely operating the packaging equipment to perform packaging functions such as filling, labeling, and packing containers in accordance with Packaging batch record while following SOPs and Maintaining 100% cGMP & compliance during operations.

Job Summary:

The Paralegal is a key member of the legal team assisting the Chief Legal Officer in managing all legal matters for the company by providing paralegal support. Serves as the intermediary between the Chief Legal Officer, internal stakeholders, the Board of Directors, and external attorneys. 

Reporting Relationships                                

  •  This position has no direct reports.

Essential Functions:

  • Set up and operate packaging lines.
  • Assist operators in performing their job functions.
  • Trouble shooting and correcting machine operation.
  • Assist team in meeting packaging production requirements.
  • Assist with training of personnel.
  • All other job-related duties.

Specialized Skills and Knowledge:                 

  • High school or GED. 
  • Packaging operator qualification. 
  •  Minimum three years of experience in packaging. 
  •   Experienced in all aspects of running bottle packaging machinery.
  •  Basic mathematical skills.
  • Ability to read and write English.
  •  Must complete departmental SOP, GMP and Qualification.
  • Good mechanical aptitude.
  • Ability to lead a team.
  •  Good dexterity and eye-hand coordination.
  • Walking, standing and ability to lift 20 Kg (44 lbs.).

Key Competencies:

  1.  Problem solving and mechanical skills 
  2. Collaboration 
  3. Adaptability and initiative

Physical Demands/Factors:

While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision. 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.


Job Features

Job CategoryManufacturing, Packaging

Job Summary: Packaging Operator is an entry-level position in the packaging department. Packing Operator is responsible for setup, cleanup, and safely operating the packaging equipment to perform pack...

Regular
16 Elkins Road, East Brunswick, NJ 08816
Posted 1 month ago

Job Summary:

Act as an independent reviewer and evaluator to ensure that Quality Compliance issues/concerns within the organization are being appropriately evaluated, investigated, and resolved. Monitors and Performs cGMP audits of all manufacturing units, contract manufacturers, contract packagers and vendors for regulatory agency review (i.e., FDA, DEA, etc.). Ensures that all Avet Laboratories sites are continually in a state of cGMP inspection readiness by driving compliance of all applicable cGMP Regulations and has ownership for cGMP Compliance Training.

Reporting Relationships                                

Individual contributor. However, depending on the need, the role can also be converted to a supervisory role.

Essential Functions:

  • Always monitor and drive cGMP inspection readiness through ensuring cGMP compliance to regulatory requirements as well as any other statutory rules applicable in the development, manufacturing, and packaging of products.
  • Develop, implement, and maintain quality compliance strategies to be in line with the business goals.
  • Formulate quality compliance policies, guidelines, and systems to ensure that the quality of the company products, processes and procedures follow all applicable cGMP regulations.
  • Interpret and ensure compliance to applicable regulations, guidelines, and advising senior management on relevant business needs.
  • Develop, implement, and maintain periodic (Quarterly) reviews of these systems and recommend corrective actions as appropriate.
  • Work in partnership with all departments (i.e., Research and Development, Engineering, Technical Services, Manufacturing as well as other applicable functions), to develop processes and procedures related to quality compliance for cGMP activities.
  • Participate and contribute to vendor development and qualification program. Also audit the vendors (raw material, packing material, contract testing laboratories, or other service providers) as per in-house SOP to ensure that all the vendors are complying with cGMP standards.
  • Develop, implement, and maintain a robust Internal (Self Inspection) auditing program in line with cGMP expectations.
  • Coordinate regulatory, customer, vendor audits and to make sure that the all the audit observations are adequately addressed.
  • Investigate reports of alleged noncompliance and working with appropriate personnel, including HR, ensure appropriate and consistent application of any compliance related disciplinary action.
  • Maintain a database of all the relevant FDA 483 observations/ Warning Letters and use them as a training tool to inform and educate employees of the “DO’s” and “Don’t”.
  • Manage projects, including developing task lists and scheduling meetings.
  • Apply the most current knowledge of how to manage regulatory inspections and follow applicable regulations. This at times requires making recommendations to change existing processes, equipment and or systems,
  • Coordinate regulatory, customer, vendor audits and to make sure that the all the audit observations are adequately addressed.
  • Actively participate in Quality Management Review.
  • Investigate reports of alleged noncompliance and working with appropriate personnel, including HR, ensure appropriate and consistent application of any compliance related disciplinary action.
  • Maintain a database of all the relevant FDA 483 observations/ Warning Letters and use them as a training tool to inform and educate employees of the “DO’s” and “Don’t”.
  • sometimes at considerable cost to company or vendor partner.
  • Review and authorize (Approve/Reject) Quality System tasks on behalf and / or in the absence of Head QC and QA. With regard to cGMP compliance, the Vice President Quality and cGMP Compliance shall be responsible in absentia of the job holder.

Requirements             

Minimum of a Bachelor of Science in Biology, Chemistry, Biochemistry, Pharmacy, or related field. 

  • 5 – 7 years of experience compliance oversight and auditing of all associated companies (providers, etc.) within the cGMP regulated environment.
  • Strong knowledge of cGLP and cGMP audits.
  • Strong knowledge of domestic and international regulatory requirements related to cGMP regulated manufacturing
  • Strong understanding of policies, guidelines and systems related to quality programs
  • Experience with Federal DEA Regulations and practical industrial oversight experience for DEA related activities.
  • Knowledge of Microsoft Office – Word, Excel, and PowerPoint primarily 
  • Certifications like ASQ is a plus

Key Competencies:

Problem solving abilities through various investigative techniques

  • Effective and professional interpersonal skills
  • Strong verbal and written communication skills
  • Staff management and leadership skills

Physical Demands/Factors:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to travel via car, train, or plane, stand, sit, walk, see, hear; use hands and fingers regularly, handle, or feel objects, tools, or controls, and reach with hands and arms.

The employee must frequently lift and/or move up to 5 pounds and occasionally lift and/or move up to 40 pounds.

Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.


Job Features

Job CategoryQuality

Job Summary: Act as an independent reviewer and evaluator to ensure that Quality Compliance issues/concerns within the organization are being appropriately evaluated, investigated, and resolved. ...

Full Time
1 Tower Center Blvd, Suite 1700, East Brunswick
Posted 2 months ago

Job Summary:

This role is a Hybrid role - requiring 3 days in the office at our East Brunswick, NJ office and 2 days remote.

Job Summary:

The Paralegal is a key member of the legal team assisting the Chief Legal Officer in managing all legal matters for the company by providing paralegal support. Serves as the intermediary between the Chief Legal Officer, internal stakeholders, the Board of Directors, and external attorneys. 

Reporting Relationships                                

This position has no direct reports.

Essential Functions:

  • Implement and maintain new matter management system.
  • Provide corporate governance support by managing corporate filings, minute books (paper and digital), entity records, and related documents and formalities.
  • Provide support for litigation, corporate and transactional matters
  • Assist in drafting, preparing, and/or proofing and managing several different types of commercial agreements and contracts (typically from templates or samples), including supply agreements, license agreements, tech transfer agreements, CDA/NDAs etc.
  • Assist with preparation, assembly of board, board committees, and other meeting materials and minutes.
  • Identify and summarize legal issues and prepare reports for attorney review.
  • Develop and maintain calendar system to track contract renewals, expiration dates, and compliance obligation deadlines.
  • Proofread, edit, revise, and redline legal documents with a high degree of accuracy and promptness.
  • Organize and maintain electronic and paper files.
  • Assist with outside counsel invoice review and approval.
  • Manage projects, including developing task lists and scheduling meetings.
  • Assist with regulatory filings.
  • Assist with litigation matters, including supporting “legal hold” and discovery processes.
  • Assist with the Company’s compliance with State Price Reporting obligations.
  • Route contracts and other documents internally and externally via DocuSign.
  • Perform special projects and other related duties as assigned.
  • Adhere to all safety and cGMP standards and guidelines, and report unsafe conditions, near misses, and/or injuries in a timely manner.

Specialized Skills and Knowledge:                 

  • Bachelor’s degree and paralegal certificate 
  • Minimum 3 years’ work experience as a Paralegal in a law firm or with an in-house legal department
  • Working knowledge of legal terminology and legal writing
  • Proficiency with legal research tools (preferred)

Key Competencies:

  1. Ability to work independently on projects requiring a high level of discretion and confidentiality
  2. Proficiency with Microsoft Office Suite including Word, Excel, Outlook, PowerPoint and Adobe Acrobat Suite
  3. Strong organizational and time management skills
  4. Excellent written and verbal skills

Physical Demands/Factors:

Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you qualify for a reasonable accommodation based on a sincerely held religious belief or medical need.

 Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.

Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.


Job Features

Job CategoryLegal

Job Summary: This role is a Hybrid role – requiring 3 days in the office at our East Brunswick, NJ office and 2 days remote. Job Summary: The Paralegal is a key member of the legal team assistin...

1st Shift
21 Cotters Lane, East Brunswick
Posted 3 months ago

Job Summary:
 The Production Helper I is responsible for assisting the Manufacturing Operators on all equipment, including but not limited to dispensing, blending, coating, compression, encapsulation, granulation, and softgel. Following company Standard Operating Procedures, the Production Helper I will assist set-up, sanitization and cleaning of equipment. This position is responsible for adhering to current Good Manufacturing Practice (cGMP) guidelines and all Environmental, Health and Safety guidelines as well as maintaining high standards in compliance and quality.


Reporting Relationships

  • Individual Contributor

Essential Functions:

Assists Manufacturing Operators and Helper II in the production cycle including set-up, sanitization and cleaning.

  • Accurate and punctual completion of document activities on batch record and logbooks
  • Adheres to cGMP’s and SOP’s as required
  • Reports any process or material discrepancies or atypical observations to the supervisor or designee
  • Support ongoing production through efficiency, schedule and teamwork
  • Handles materials used in productions such as moving pallets, containers and equipment
  • Maintain good housekeeping and keeps equipment and environment clean in accordance with SOP’s
  • Offer suggestions and follow up on process improvements related to safety, compliance, cost, and productivity
  • All other duties as assigned

Specialized Skills and Knowledge:

 High school diploma with 6 months+ experience in pharmaceutical manufacturing

  • Basic math skills
  • Excellent verbal and written communication skills in English
  • Ability to work in a team and collaborate with other departments
  • Familiar with cGMP’s and operates in adherence to SOP’s

Key Competencies:

Multitasking

  1. Flexibility
  2. Versatility

Physical Demands/Factors:        

While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, and color vision.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you qualify for a reasonable accommodation based on a sincerely held religious belief or medical need.

Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements

Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

Apply Online

Job Features

Job CategoryProduction/Manufacturer, Quality

Job Summary: The Production Helper I is responsible for assisting the Manufacturing Operators on all equipment, including but not limited to dispensing, blending, coating, compression, encapsulat...

Regular
Posted 3 months ago

Job Summary:
This person currently in this position in AMV is primarily responsible to gather data/results from AMV studies and present in a technical report for submission. Additionally, he is also given the responsibility for assisting in ordering chemicals, standards, and Lab consumables for the AMV group. The person is also responsible to organize, and store written protocols, reports, folders with chromatograms/ UV spectrums and books in orderly fashion and archive with the QA group as needed for the AMV group. 


Reporting Relationships

  • This position directly reports to the Group Leader AMV.

Essential Functions:

The position includes Over-seeing of the following activities but not limited to:

  • Prepare Analytical Method Validation/Verification/Transfer Reports for method validation group per written procedures and cGMP Guidelines.
  • Be able to review Written Technical Protocols and Methods for Method Validation Studies. 
  • Assist method validation department for general tasks including ordering of chemicals, HPLC accessories and other Consumables for the AMV group.
  • As needed perform additional duties for Quality Control (AMV) Department. 
  • Upkeep the AMV group with respect to organizing and storing written protocols, reports, folders with chromatograms/ UV spectrums and books in orderly fashion and archive with the QA group as needed for the AMV group.

Specialized Skills and Knowledge:

  • Minimum BS in Chemistry or related field. Computer knowledge for executing Words, Excel is mandatory. Report Writing Experience will be considered as a plus.
  • Prepare and review documentation (reports and other relevant doc.) on new product development with respect to Quality Control, Method Validation and R&D. Critic and corrects the reports as needed with feedback from Associate Manager/Associate Director AMV. Should be able to review protocols.
  • Conducts literature searches for new method development projects (AR&D) utilizing chemical, medical, analytical and scientific abstracts.  Requires knowledge of product areas, current developments and keeping update of current literature.
  • Preparation of analytical documents (Reports) for regulatory submission for FDA deficiencies, Transfer products and Development projects in conjunction with upper management.
  • Collects and maintains product documentation files & folders, Guidelines and Literatures.
  •  Understands and applies USP monographs & general chapters.
  • All other job-related duties with respect to ordering of Chemicals, HPLC Accessories,Consumables, etc. for the AMV department.

Key Competencies:

  1. SBasic Knowledge of a variety of laboratory instruments including many of the following: HPLC, UV/Vis spectrophotometer, pH meter, analytical balances, moistures, hardness friability.
  2. Understands and uses good quantitative techniques in performing analytical tests calculations.
  3. Computer skills for data processing/storage.
  4. Has the ability to understand and follow written methodologies in accordance with cGMP standards

Physical Demands/Factors:        

While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision. 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you qualify for a reasonable accommodation based on a sincerely held religious belief or medical need.

Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements

Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

Apply Online

Job Features

Job CategoryQuality

Job Summary:This person currently in this position in AMV is primarily responsible to gather data/results from AMV studies and present in a technical report for submission. Additionally, he is also gi...

Regular
1 Tower Center Blvd, Suite 1700, East Brunswick
Posted 3 months ago

Note- Level of the role will be determined based on the candidate's experience and understanding of the pharmaceutical market

Job Summary:
The main responsibility of the National Accounts Manager is to present the Avet portfolio to the assigned accounts and secure sales of existing and future products to achieve the sales goals of the company. The National Accounts Manager will manage all aspects of the accounts including but not limited to sales presentations, pricing requests, service level calls, etc. The National Accounts Manager will communicate by phone, email, and in-person meetings as necessary to provide the best customer service possible. The National Accounts Manager is expected to understand the Generic Pharmaceutical market and provide market intelligence to Senior Management to inform sound financial and strategic decisions. The National Accounts Manager is expected to operate under all of Avet’s compliance guidelines and use company funds in a judicious and ethical manner.


Reporting Relationships

  • This is an individual contributor

Essential Functions:

  • Utilize effective selling techniques and marketing strategies to create and expand demand for any/all Avet products for which you are responsible for achieving overall sales objectives and goals.
  • Maintain and expand existing customer relationships across the Retail and Wholesale channels.
  • Participate in developing new product launch strategies.
  • Qualifies potential new customers and executes on setup of key new accounts.
  • Support and interface with Contracts and Pricing department to complete customer RFPs, inquiries and bids.
  • Responsible for aiding in the development, design, and direction of sales and marketing plans.
  • Effectively manage, time, resources, and workload.
  • Participate in Sales Planning and Operations Meetings to effectively communicate customer’s needs within the organization.
  • Coordinate and arrange travel for customer meetings and trade shows up to 50% of the time.
  • Adhere to all safety and cGMP standards and guidelines, and report unsafe conditions, near misses, and/or injuries in a timely manner.

Specialized Skills and Knowledge:

  • Bachelor’s degree required
  • Must have a minimum of 5+ years of Generic Pharmaceutical Sales experience
  • Understanding of the Pharmaceutical market landscape

Key Competencies:

  1. Strong verbal and written communication skills as well as presentation skills.
  2. Must have strong working knowledge of Microsoft Office, and other PC-related applications. SAP experience is preferred.
  3. Must be detail-oriented, organized, and possess a strong customer orientation.
  4. Proven track record for delivering consistent and strong sales results.

Physical Demands/Factors:        

This role is remote-based. #LI-Remote                                                 

Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you qualify for a reasonable accommodation based on a sincerely held religious belief or medical need.

Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements

Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

Apply Online

Job Features

Job CategoryCommercial Ops

Note- Level of the role will be determined based on the candidate’s experience and understanding of the pharmaceutical market Job Summary:The main responsibility of the National Accounts Manager...

1st Shift
21 Cotters Lane, East Brunswick
Posted 4 months ago

Job Summary:

 The Production Helper I is responsible for assisting the Manufacturing Operators on all equipment, including but not limited to dispensing, blending, coating, compression, encapsulation, granulation, and softgel. Following company Standard Operating Procedures, the Production Helper I will assist set-up, sanitization and cleaning of equipment. This position is responsible for adhering to current Good Manufacturing Practice (cGMP) guidelines and all Environmental, Health and Safety guidelines as well as maintaining high standards in compliance and quality.


Reporting Relationships

  • Individual Contributor

 Essential Functions:

 Assists Manufacturing Operators and Helper II in the production cycle including set-up, sanitization and cleaning.  

  • Accurate and punctual completion of document activities on batch record and logbooks
  • Adheres to cGMP’s and SOP’s as required
  • Reports any process or material discrepancies or atypical observations to the supervisor or designee
  • Support ongoing production through efficiency, schedule and teamwork
  • Handles materials used in productions such as moving pallets, containers and equipment
  • Maintain good housekeeping and keeps equipment and environment clean in accordance with SOP’s
  • Offer suggestions and follow up on process improvements related to safety, compliance, cost, and productivity
  • All other duties as assigned
     

Specialized Skills and Knowledge:                                                                 

 High school diploma with 6 months+ experience in pharmaceutical manufacturing

  • Basic math skills
  • Excellent verbal and written communication skills in English
  • Ability to work in a team and collaborate with other departments
  • Familiar with cGMP’s and operates in adherence to SOP’s


Key Competencies:

 Multitasking

  1. Flexibility
  2. Versatility

Physical Demands/Factors:

While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, and color vision.    

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you qualify for a reasonable accommodation based on a sincerely held religious belief or medical need.

Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.

Avet is proud to be an Equal Opportunity Employer.

Apply Online

Job Features

Job CategoryProduction/Manufacturer

Job Summary:  The Production Helper I is responsible for assisting the Manufacturing Operators on all equipment, including but not limited to dispensing, blending, coating, compression, encapsula...

Regular
21 Cotters Lane, East Brunswick
Posted 5 months ago

Job Summary:

Investigation/Technical Writer is responsible for investigating, preparing, reporting and
documentation of laboratory deviations, out of specification investigations, microbial non
conformances and complaints that are reported. Compliance investigator completes the
investigations and closure of the incidents/CAP As within the time frame. Quality Control
Investigation/technical writer assist QC management and perform other documentation work as
required for change controls, QCMs, SOPs, specifications, protocols etc. The Investigation/technical
writer directly reports to Associate Director/Director of Quality Control and assist in all laboratories
related documentation as necessary.


Reporting Relationships

  • This position has no direct reports

Essential Functions:

  • As part of each investigation, gather information from all necessary internal and external sources in order to find the root cause and to evaluate the impact of the deviation/investigation on drug substance or drug product, as well as the risk.
  • The Investigation/technical writer will conduct and drive events/lab deviations/out of specification investigation, Microbial nonconformance to identify root cause, product impact and preventative actions for Quality Control department in support of batch disposition and continuous process improvement. Work with internal teams to obtain an in-depth understanding of documentation requirements.
  • Work across functions with a professional manner to conduct investigations and works independently to comply with procedure driven guidelines related to lab deviations/out of specification investigations, Microbial nonconformances.
  • Preparation and revision of specifications, Standard Operating Procedures (SOPs), Quality Control Methods, Protocols, technical reports and initiate change controls.
  • Produce high-quality investigation documentation that meets applicable standards and is appropriate for its intended audience.
  • Properly assess the analytical environment and independently conceives and initiates appropriate corrective/preventative actions (CAPAs) designed to mitigate Quality deficiencies identified in the investigative process using analytical tools.
  • Track the progress of the open CAPAs and ensure closure of the CAPAs in timely manner.
  • Prepare monthly, quarterly and annual investigations/CAPAS trend reports.
  • Ensure completion of training to new hires per procedure and training to current employees as and when needed
  • Review and perform SAP transactions.
  • Discover and report any trends in reported deviations/investigations.
  • Conduct training to employees based on the deviations/CAPAs.
  • Additional duties as assigned based on business needs.


Specialized Skills and Knowledge:    

  • Education/Certifications: BS degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience; 3+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices
  • Pharmaceutical or related FDA work experience strongly preferred.
  • Must know the laboratory related equipment's to understand.
  • Demonstrates strong analytical and technical skills.
  • Ability to articulate, discuss and get information from Manufacturing, QC, QA, RA and engineering personnel to write a complete investigation.
  • Excellent verbal communication and strong written English skills with a proven record of producing technical reports in a clear and concise manner.
  • Strong experience and comprehension of MS Office programs - primarily MS Word and excel.
  • Assures compliance to all procedures and policies concerning all areas of manufacturing, logistics, safety and human resources.
  • Reviews of documents for accuracy of entries, compliance to established limits, specifications and presence of all verification signatures.
  • Must be able to work in fast paced environment.
  • Previous technical writing experience preferred.
  • Other duties as assigned.


Physical Demands/Factors:

Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required.
 The physical demands described here are representative of those that must be met by an employee
to successfully perform the essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the essential functions.


At Avet, we require that all employees physically entering the workplace to be fully vaccinated
against COVID-19, and you will be asked to present proof of vaccination before beginning
employment unless you qualify for a reasonable accommodation based on a sincerely held religious
belief or medical need.


Based on the highly regulated workplace at Avet, employees will be required to meet minimum
English proficiency requirements.


Avet is proud to be an Equal Opportunity Employer.


This job description is not all-inclusive. It acts as a guideline and is subject to change
over time. Additional duties may be assigned based on business needs.

Apply Online

Job Features

Job CategoryQuality

Job Summary: Investigation/Technical Writer is responsible for investigating, preparing, reporting anddocumentation of laboratory deviations, out of specification investigations, microbial nonconforma...

1st Shift
21 Cotters Lane, East Brunswick
Posted 7 months ago

Job Summary:

Production Cleaner will be responsible for the cleaning of the manufacturing facility and maintain high standards and Safety and cGMP practice.

Reporting Relationships:

  • This position has no direct reports.

Essential Functions:

  • Follow SOP and clean manufacturing facility to keep buildings clean and well maintained which includes dusting, sweeping, vacuuming, mopping, cleaning of manufacturing area, washroom, cafeteria, etc.
  • Operate Floor Scrubbing machine.
  • Perform cleaning of vessels, containers, equipment in the washroom.
  • Perform stocking and supplying personal protective equipment and cleaning agents to designated facility areas.
  • All other job-related duties which includes material handling, staging, labeling.

Specialized Skills and Knowledge:

  • High School diploma with 2 years related experience.
  • Adhere to housekeeping, safety and environmental practices

Key Competencies:

  1. Multitasking.
  2. Flexibility.
  3. Versatility.

Physical Demands/Factors:

While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 44 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision. 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you qualify for a reasonable accommodation based on a sincerely held religious belief or medical need.

Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.

Avet is proud to be an Equal Opportunity Employer.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

Apply Online

Job Features

Job CategoryManufacturing, Production

Job Summary: Production Cleaner will be responsible for the cleaning of the manufacturing facility and maintain high standards and Safety and cGMP practice. Reporting Relationships: This position has ...