Job Description:

Description:

The Group Leader, QA will lead, schedule and coordinate daily priorities for incoming raw materials sampling, release, reject, hold and inspection/in process QA Support/Packaging/Auditing activities in manufacturing and packaging areas. The group leader QA will train, coach and mentor QA Inspectors / Auditors on regular QA sampling, Room/ Equipment / batch release processes for training purposes. He/she will monitor and ensure all phases of drug manufacturing are in compliance with established specifications. Will ensure quality compliance before, during and after each manufacturing and packaging run. Will review production batch reviews for manufacturing and packaging work orders and determine batch disposition.

Essential Functions:

• All requirements of QA Inspector III and QA Auditor II, in addition to assisting the supervisor in maintaining documentation and training for QA inspectors and auditors as well as maintaining the area training matrix


• Will review annual Stability Check Lot Program, hold reconcile NOI batches in JD Edwards, annual cleaning validation cleaning program tracking


• Will assist prioritizing and completing reviews of manufacturing records and packaging orders in a timely manner.


• Will be involve in business critical sample submissions and tracking to respective labs.


• Will be responsible in data collection for closure of investigations, assessments, planned deviations


• Analyze RFT Data and provide trending reports to QA/OPS Supervisors and Managers.

Additional Responsibilities:

• Must be able to fill in for In-process QA inspectors/auditors when needed.

Education:

• High School or GED - Required


• Bachelors Degree (BA/BS) - Preferred

Experience:

• 4 years or more in QA or related field

Skills:

• Good basic math knowledge and excellent attention to details - Intermediate


• Excellent organizational skills with proficiency in MS Word, Excel, and Powerpoint - Intermediate


• Ability to produce sufficient work within the stipulated time - Intermediate


• High energy level and organizational skills - Intermediate


• Excellent knowledge of manufacturing processes from Raw Material Receipt through finished goods packaging - Intermediate

Specialized Knowledge:

• Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, ICH guidelines

Licenses:

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.

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