QA Operations Lead - Sterile Manufacturing

American Regent, Inc.; New Albany (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

American Regent, Inc. seeks a QA Operations Manager to lead QA operations at a sterile manufacturing site.

This role reports to the QA Manufacturing Operations Manager and focuses on supervising QA Technicians, guiding investigations of deviations, CAPAs, and regulatory compliance during daily production. Requirements include a Life Sciences or related degree and at least 2 years in QA/regulatory/pharma operations in a cGMP environment, plus 1 year of leadership.

Qualifications

• Bachelor’s or Associate’s degree in life sciences, business or related field.
• Minimum 2 years in QA, regulatory, compliance or pharmaceutical operations in a cGMP environment.
• Minimum 1 year of leadership experience.

Responsibilities

• Supervise QA Technicians to oversee daily production activities including materials receipt/release, manufacturing and packaging.
• Lead on-site QA activities in investigating deviations or compliance issues.
• Identify and facilitate resolution of quality issues including deviations, investigations and CAPA with senior QA staff.
• Identify and facilitate quality process improvements to increase efficiencies.
• Write and revise SOPs and other GMP documentation.
• Ensure all work complies with company policies, cGMP and health and safety requirements.
• Perform other tasks as assigned by management.

Skills

Leadership experience

Quality oversight

GMP knowledge

Regulatory knowledge

Communication skills

Problem solving

Education

Associate’s or Bachelor’s Degree in Life Sciences, Business or related field

Job description

American Regent, Inc. seeks a QA Operations Manager to lead QA operations at a sterile manufacturing site.

This role reports to the QA Manufacturing Operations Manager and focuses on supervising QA Technicians, guiding investigations of deviations, CAPAs, and regulatory compliance during daily production. Requirements include a Life Sciences or related degree and at least 2 years in QA/regulatory/pharma operations in a cGMP environment, plus 1 year of leadership.