Supervisor, Quality Assurance

Amneal Pharmaceuticals • Piscataway, NJ

391d

About The Position

The Supervisor, Quality Assurance is responsible for overseeing the scheduling and coordination of daily priorities related to raw materials, in-process testing, and finished product sampling. This role ensures compliance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP) across all quality assurance activities, including training and evaluating QA staff.

Requirements

• Experience in Quality Assurance within a manufacturing environment.
• Strong knowledge of cGMP and SOP compliance.
• Proven ability to train and supervise QA staff effectively.
• Experience in handling customer complaints and conducting investigations.

Nice To Haves

• Familiarity with FDA regulations and internal auditing processes.
• Experience with validation and qualification studies.

Responsibilities

• Schedule and coordinate daily priorities for raw material, in-process material, and finished product sampling and inspection activities.
• 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, and execute validation and qualification studies.
• Perform investigations and handle Change Controls, Deviations, and CAPA using effective quality management tools.
• Manage customer complaints, including sample retrieval, testing, and report preparation.
• Audit batch records for compliance with manufacturing, packaging, and shipping requirements.
• Conduct internal audits for compliance with SOP, cGMP, and FDA requirements.
• Initiate 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.
• Prepare Kronos and HR requisitions/data change forms for shift personnel as needed.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Professional development opportunities

What This Job Offers

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