Supervisor Quality Control, Analytical Laboratory
$81.65k - $112.7kIntegra LifeSciences Corporation
Integra LifeSciences seeks a Supervisor for Quality Control Analytical Laboratory in Braintree, MA, to lead analytical testing operations supporting product release, validation, and stability studies. The role requires technical oversight of laboratory personnel, compliance with FDA and ISO 13485 standards, and coordination across manufacturing and quality functions.
Responsibilities
- Supervise daily QC analytical laboratory operations and ensure timely, accurate testing execution
- Oversee analytical testing of raw materials, in-process materials, finished products, and stability samples
- Provide technical oversight of analytical chemistry systems, troubleshooting, and data review
- Lead, coach, and manage laboratory personnel performance and competency development
- Review and approve laboratory data, records, and quality documentation for accuracy and compliance
Requirements
- Bachelor's degree in Chemistry, Biochemistry, Biology, Engineering, or related scientific discipline
- Minimum 7 years GMP/GLP laboratory experience in FDA-regulated industries
- Minimum 2 years supervisory or technical leadership experience
- Strong knowledge of FDA QMSR, 21 CFR Part 820, and ISO 13485 requirements
- Experience with analytical method validation, verification, and transfer activities
- Hands-on expertise with material characterization instruments and mechanical testing systems
- Experience managing OOS/OOT investigations, nonconformances, and CAPA activities
Vacancy posted 26 days ago
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