QA Operations Supervisor

American Regent • New Albany, OH

4d • Onsite

About The Position

This position, reporting to the QA Manufacturing Operations Manager, is responsible for leading QA Operations activities at a sterile manufacturing site. The role involves supervising QA Technicians to ensure timely and quality oversight of daily production activities, including materials receipt/release, manufacturing/filling, and packaging. The position also leads on-site QA activities for investigating deviations or compliance issues, identifies and facilitates the resolution of quality issues (deviations, investigations, CAPA), and drives quality process improvements to enhance system, operation, and personnel efficiencies and performance. Additionally, the role involves writing and revising SOPs and other GMP documentation, ensuring all work adheres to company policies, procedures, cGMP, and health and safety requirements.

Requirements

• Associate’s or Bachelor’s Degree in Life Sciences, Business or related field is required.
• Minimum of 2 years of work experience in QA, Regulatory, Compliance or Pharmaceutical Operations in a cGMP environment is required.
• Minimum of 1 year leadership experience required.
• Extensive knowledge of cGMPs and other regulatory standards for Finished Product manufacturing.
• Demonstrated success in managing multiple activities at the same time and producing outstanding results.
• Excellent organizational, interpersonal and communication skills (oral and written).
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves.
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

Nice To Haves

• Experience in sterile pharmaceutical manufacturing preferred.

Responsibilities

• Supervise QA Technicians to assure timely and quality oversight of daily production activities including materials receipt/release, manufacturing/filling and packaging.
• Lead on-site QA activities in investigating deviations or compliance issues associated with daily manufacturing operations.
• Identify and facilitate the resolution of quality issues including deviations, investigations and CAPA in conjunction with senior QA staff.
• Identify and facilitate quality process improvements to increase efficiencies and performance of systems, operations and personnel.
• Write and revise SOP’s and other GMP documentation.
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.
• Perform any other tasks/duties as assigned by management.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree