QA Operations Supervisor

About the role

This position reports to the QA Manufacturing Operations Manager and is responsible for leading QA Operations activities at a sterile manufacturing site.

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.

Requirements

• Associate’s or Bachelor’s Degree in Life Sciences, Business or related field required.
• Minimum of 2 years of work experience in QA, Regulatory, Compliance or Pharmaceutical Operations in a cGMP environment required.
• Minimum of 1 year leadership experience required.
• Experience in sterile pharmaceutical manufacturing preferred.
• 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 gowning, goggles, face shields, and protective gloves; PPE is essential for health and safety.
• Specific vision requirements include 20/20 near vision (correctable with eyeglasses or contacts) and color vision.