Job Description
Description
EXECUTE and SUPPORT • Perform on-the-floor Quality Assurance oversight of GMP manufacturing operations. • Review executed batch records and GMP documentation for accuracy, completeness, and compliance. • Support investigations, deviations, CAPAs, and change controls under guidance from senior QA staff. • Escalate quality events, compliance risks, and atypical observations in a timely manner. • Partner with Manufacturing, QC, and support functions to ensure adherence to approved procedures. • Support internal audits, client audits, and inspection readiness activities. • Maintain knowledge of applicable GMP regulations, site procedures, and quality systems.
Additional Skills & Qualifications
Minimum of 2–4 years of GMP industry experience with a Bachelor’s degree in Life Sciences or Chemical/Biochemical Engineering. 2–4 years of hands-on experience supporting CAPA, deviations, change control, and document control within a GMP manufacturing environme...
EXECUTE and SUPPORT • Perform on-the-floor Quality Assurance oversight of GMP manufacturing operations. • Review executed batch records and GMP documentation for accuracy, completeness, and compliance. • Support investigations, deviations, CAPAs, and change controls under guidance from senior QA staff. • Escalate quality events, compliance risks, and atypical observations in a timely manner. • Partner with Manufacturing, QC, and support functions to ensure adherence to approved procedures. • Support internal audits, client audits, and inspection readiness activities. • Maintain knowledge of applicable GMP regulations, site procedures, and quality systems.
Additional Skills & Qualifications
Minimum of 2–4 years of GMP industry experience with a Bachelor’s degree in Life Sciences or Chemical/Biochemical Engineering. 2–4 years of hands-on experience supporting CAPA, deviations, change control, and document control within a GMP manufacturing environme...