Quality Assurance Team Lead
Core
Lead QA Operations personnel in GMP manufacturing and packaging environments, ensuring compliance with cGMP standards and FDA regulations through audits, testing, and monitoring.
Role type
Senior IC Quality Assurance Team Lead
Builds
Manufacturing and packaging processes compliant with cGMP and FDA regulations
Domain
Life Sciences / Pharma / Biotech / Manufacturing
Required skills
GMP compliance, cGMP standards, FDA regulations, SOP writing and review, batch record review, root cause analysis, CAPA management, team leadership, risk assessment, deviation management
Preferred skills
Manufacturing operations experience, laboratory operations experience, pharma or biotech industry experience
Technologies
GMP, cGMP, FDA regulations, SOPs, batch records, MSAT reports
Responsibilities
Ensure QA Operations personnel engage on the GMP manufacturing and packaging floor; Perform document reviews of SOPs, batch records, test methods, and logbooks; Independently write and approve SOPs and Master Batch Records; Assess potential impact to product quality for open deviations during lot release; Participate in investigations into minor/major root cause, corrective or preventive actions; Lead, train, develop, manage, and retain a team of QA Operations personnel; Adhere to Safety and Sustainability requirements and report issues promptly.
Seniority
Senior, hands-on IC with leadership responsibilities