QUALITY ASSURANCE ASSOCIATE

2nd Shift
16 Elkins, East Brunswick
Posted 3 months ago

Job Summary:

This position exists to create what outcomes? What are the primary functions of this role? Use current metrics in the description of desired outcomes and list the desired outcomes in order of importance. As examples, you may speak to what degree this position influences Avet’s revenue and expenditures, or its development and delivery of products and services or its readiness for audits, or the dollar amount of the end results for which the position is either accountable (e.g., sales volume, assets, net budget, payroll, etc.) or which it supports, types of data collection and input, types of data analyzed and reports created, etc.

Reporting Relationships    

•    This position has no direct reports.

Essential Functions:

01.    Determine whether quality activities and related results comply with cGMP requirements.
02.    Perform and monitor all production floor QA related functions for the Soft-gel Manufacturing process.
03.    Perform and monitor all production floor QA related functions for the manufacturing process for solid dosage (tablets and hard gelatin capsules) and drug products in powder form.
04.    All the QA related functions required must be performed and carried out as per established company standard and procedures and assure that manufacturing/production is according to cGMP regulation.
05.    The typical tasks/activity performed as the production floor QA are listed here but not limited to such as:
•    Logbook maintenance on daily and calendar basis
•    Providing required approval for production activity and make appropriate entries in respective batch manufacturing records/MMR.
•    Verify raw material and components prior to usage as required and checking and monitor the dispensing/weighing process.
•    Check the cleanliness and provide usage approval of equipment and production rooms in the production department namely granulation, Tableting, Encapsulation, Coating, Soft-gel, and Packaging.
•    Collect granulation, tablet, capsule, soft-gel, and packaging samples at various stages of production.
•    Perform and collect in-process samples e.g. for individual blend samples for uniformity, and composite samples and submit it for QC testing.
•    Perform drying curve sampling and verification of moisture by the Ohaus Moisture analyzer.
•    Perform Hardness, AQL DT Friability and Thickness testing of tablets
•    From QA perspective participate and monitor IQ-OQ-and PQ and Preventive maintenance of production equipment.
•    Process validation, process characterization, cleaning validation, and time limit validation monitoring
•    Provide approvals for the setup of machines and commencement of production.
•    Assist packaging operation whenever required.

Specialized Skills and Knowledge:

•    Minimum Associate degree with Chemistry as a major subject alternatively minimum of 3 years of experience in working as a floor QA for a pharmaceutical company
•    Knowledge about various Oral Solid Dosage manufacturing activity (dispensing, blending, granulation, compression, coating, Packaging, etc.
•    Knowledge of In-process testing like – Hardness testing, Thickness testing, Disintegration testing, Friability testing, etc. including the knowledge of related instruments.
•    Basic knowledge of working on computers – MS Office.

Key Competencies:

1. Analytical Skills
2. Problem Identification and Solving Skills
3. Communication Skills in English

Physical Demands/Factors:

While performing the duties of this job, the employee is regularly required to mover around the production floor. The employee is regularly required to move around various buildings of Avet. The employee must occasionally lift and or move up to 25 pounds.

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 CategoryQuality Assurance

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