QA Operations Lead, Sterile Pharma Manufacturing

American Regent, Inc.; New Albany (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

American Regent, Inc. seeks a QA Operations lead to oversee activities at a sterile manufacturing site, reporting to the QA Manufacturing Operations Manager. You will supervise QA Technicians and ensure timely, quality oversight of production operations, including materials receipt, manufacturing and packaging.

The role emphasizes investigating deviations, CAPA coordination, SOP maintenance, and adherence to cGMP and health and safety standards. Strong leadership and communication are essential.

Qualifications

• 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.
• 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).

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.

Skills

Leadership

GMP knowledge

CAPA investigations

Regulatory compliance

SOP documentation

Education

Bachelor's degree in Life Sciences / related field

Associate’s degree (acceptable)

Tools

Job description

American Regent, Inc. seeks a QA Operations lead to oversee activities at a sterile manufacturing site, reporting to the QA Manufacturing Operations Manager. You will supervise QA Technicians and ensure timely, quality oversight of production operations, including materials receipt, manufacturing and packaging.

The role emphasizes investigating deviations, CAPA coordination, SOP maintenance, and adherence to cGMP and health and safety standards. Strong leadership and communication are essential.