QA Operations Supervisor

American Regent, Inc. • New Albany, OH

5d • 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 supervisor will lead on-site QA activities for investigating deviations or compliance issues, and identify/facilitate the resolution of quality issues, including deviations, investigations, and CAPA, in conjunction with senior QA staff. Additionally, the role involves identifying and facilitating quality process improvements to enhance efficiencies and performance, writing and revising SOPs and other GMP documentation, and ensuring all work is performed and documented in accordance with company policies, procedures, cGMP, and health and safety requirements. Any other tasks/duties as assigned by management will also be performed.

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).

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