Supervisor Quality Control, Analytical Laboratory

Role: Supervisor of QC Analytical Laboratory providing technical and operational leadership in a GMP/GLP-regulated environment. Objectives: ensure compliant analytical testing, data integrity, and lab readiness supporting manufacturing and product release. Responsibilities: oversee testing of raw materials, in-process, validation, stability, and finished products; manage laboratory personnel and resources; ensure procedures meet FDA, ISO 13485, and GMP standards; lead investigations on OOS/OOT, NC, CAPA; support validation, method transfer, and lifecycle activities; participate in audits and inspections; maintain documentation and equipment calibration. Requirements: Bachelor's in Chemistry, Biochemistry, Biology, or related field; 7+ years GMP/GLP lab experience in pharma/biotech/medical devices; 2+ years supervisory experience; strong knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485; hands-on with analytical instrumentation, method validation, and data integrity; excellent communication and leadership skills. Preferred: experience managing stability programs, validation protocols, and electronic data systems. HighValue: regulated industry expertise, analytical chemistry, mechanical testing, physical/chemical techniques, validation, data integrity, GMP/GLP compliance, auditing, and team leadership. Work setup: full-time; salary range ~$81.7K–$112.7K; additional benefits include health, dental, vision, and retirement plans.