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.

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