Senior QC Lab Lead — Analytical Excellence & Compliance

Integra LifeSciences; Braintree (MA); Vor Ort; USD 82.000 - 113.000; Vollzeit

Zusammenfassung

Integra LifeSciences is seeking a Supervisor, QC Analytical Laboratory to lead the analytical laboratory operations and ensure compliant testing for raw materials, in-process materials, and finished products. The role focuses on data integrity, method validation, and regulatory readiness.

You will oversee lab activities, manage personnel, and collaborate with Manufacturing, QA, and Engineering to support product release and continuous improvement in a cGMP environment.

Qualifikationen

• Bachelor’s degree or higher in Chemistry, Biochemistry, Biology, Engineering, or related scientific/engineering discipline.
• Minimum seven (7) years of GMP/GLP laboratory experience in FDA-regulated industry.
• Minimum two (2) years of supervisory or technical leadership experience.
• Experience with FDA QMSR, 21 CFR Part 820, ISO 13485, and quality-system requirements.
• Experience with analytical method validation/verification/transfer/investigations.
• Hands-on experience with material characterization instrumentation and analytical testing in regulated cGMP environment.

Aufgaben

• Supervise daily operations of the Quality Control Analytical Laboratory.
• Coordinate analytical testing of raw materials, in-process, finished products, and validation samples.
• Provide leadership, coaching, and performance management for lab personnel.
• Ensure testing aligns with GMP, GLP, GDP, and regulatory requirements.
• Review and approve laboratory data, records, and reports.
• Manage external contract laboratories, including sample submission and data review.
• Lead or support TMV, method transfer, and lifecycle management.

Kenntnisse

Leadership

GMP/GLP knowledge

Data integrity

Analytical chemistry

Problem solving

Ausbildung

Bachelor's degree or higher in Chemistry, Biochemistry, Biology, Engineering, or related field

Tools

LIMS

Microsoft Office

Jobbeschreibung

Integra LifeSciences is seeking a Supervisor, QC Analytical Laboratory to lead the analytical laboratory operations and ensure compliant testing for raw materials, in-process materials, and finished products. The role focuses on data integrity, method validation, and regulatory readiness.

You will oversee lab activities, manage personnel, and collaborate with Manufacturing, QA, and Engineering to support product release and continuous improvement in a cGMP environment.