Supervisor, Quality Assurance

Amneal Pharmaceuticals • Piscataway, NJ

392d

About The Position

The Supervisor, Quality Assurance at Amneal Pharmaceuticals is responsible for overseeing the quality assurance processes related to raw materials, in-process testing, and finished product sampling. This role involves scheduling daily priorities, training and supervising QA staff, ensuring compliance with regulatory standards, and managing quality-related documentation and investigations.

Requirements

• Experience in quality assurance within a pharmaceutical or related industry.
• Strong knowledge of cGMP and FDA regulations.
• Proven ability to train and supervise staff effectively.
• Experience in writing and revising Standard Operating Procedures (SOPs).
• Strong analytical and problem-solving skills.

Nice To Haves

• Experience with validation and qualification studies.
• Familiarity with quality management tools and methodologies.
• Previous experience in handling customer complaints and investigations.

Responsibilities

• Schedule and coordinate daily priorities for incoming raw materials and labeling components, in-process testing, and finished product sampling.
• Train, supervise, and evaluate the performance of QA inspectors, QA Specialists, and QA Auditors to ensure compliance with SOPs and cGMP.
• Monitor all stages of QA in-process and packaging operations to ensure compliance with cGMP and SOPs.
• Assist management in developing new and revised SOPs, executing validation and qualification studies, and performing investigations as required.
• Handle Change Controls, Deviations, and CAPA using effective quality management tools.
• Manage customer complaints, including sample retrieval, testing, report preparation, and timely submission.
• Audit batch records per manufacturing, packaging, and shipping requirements when necessary.
• Conduct internal audits for compliance with SOP, cGMP, and FDA requirements.
• Initiate, investigate, and complete CAPA for QA unplanned deviations under the guidance of the QA Manager.
• Write, review, and revise SOPs as directed by the QA Manager/Director.
• Plan, monitor, and supervise cross-training of all QA Inspectors.
• Monitor absences and prepare HR requisitions and data change forms for shift personnel as required.
• Review performance of QA Inspectors as directed by HR.

Benefits

• Health insurance coverage.
• 401k retirement savings plan.
• Paid holidays and vacation time.
• Professional development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: No Education Listed