QA Associate

Company Name:
Amneal Pharmaceuticals
QA Associate
Pay: Competitive Department: Manufacturing
Location: Piscataway, NJ Exemption: No
Summary:
Amneal Pharmaceuticals is a growing U.S. manufacturer of the highest quality generic pharmaceuticals. A dynamic and emergent company, we carefully nurture the entire product lifecycle from the early stages of R&D and API Development through FDA approval, painstakingly managed manufacturing and, ultimately, seamless supply to our customers.
Description:
The QA Associate will support manufacturing activities by ensuring compliance and quality of products.
Responsibilities:
Perform room and equipment checks prior to each stage of manufacturing and packaging following written procedures. Perform in process testing which may include but not limited to hardness, thickness, group weight, weight variation and friability. Records and review data for Temperature & Humidity throughout the facility, address discrepancies when noted. Preparation of samples for finished product, cleaning validation, process validation, microbiological analysis, swab sampling and delivering to QC lab. Performing physical testing of commercial, stability and validation batches as per procedure and protocol requirements. Prepare controlled /uncontrolled/packaged finished product sample for QC lab and QA retains, following procedure. Collection of in-process samples including, but not limited to blend uniformity, LOD and stratified samples using applicable apparatus and methods, and submitted to QC lab with appropriate documents. Collection of packaged product samples for annual stability and retain. Perform in process QA checks of Manufacturing and packaging line following written procedure. Perform AQL inspection of finished product and documented in the batch record. Submit sample to AR&D and QC Laboratories. Collection of samples to reassay bulk finished product before expiration and submitted to QC lab with appropriate documents. Disposition of rejected materials as per current procedure. Verify and audit all operational log books. Review in process production and packaging batch records.
Performs air sampling for environmental monitoring
Any additional duties and responsibility that may be added/included as assigned by Amneal management.
Requirements:
Bachelor-s Degree
1 to 2 years of Pharmaceutical experience
Superior attention to detail, highly organized.
Additional Information:
We offer a comprehensive compensation package which includes Health Insurance and an employer-matched 401(k) plan. Qualified candidates should email a resume, including salary history and requirements, to .
All qualified applicants will receive consideration for employment without regarding to race, color, religion, sex, national origin, disability or protected veteran status.
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