QC Microbiology Lab Supervisor: GMP & Compliance Leader

Integra LifeSciences Corporation; Braintree, Northern (MA, KY); Hybrid; USD 82,000 - 113,000; Full time

Job summary

Integra LifeSciences Corporation seeks a Supervisor, QC Microbiology to provide leadership for the microbiology lab, ensuring compliant testing of materials and products. You will oversee environmental and utility monitoring, maintain data integrity, and drive continuous improvement in a regulated, FDA-inspected facility.

You will supervise personnel, coordinate testing across product stages, and collaborate with Manufacturing, QA, and R&D to support product lifecycle and regulatory readiness.

Qualifications

• Bachelor’s degree or higher in Microbiology, Biology, Biochemistry, Life Sciences, or related field.
• Seven (7) years of GMP/GLP lab experience in FDA-regulated industry (medical device/pharma/biotech).
• Two (2) years of supervisory or technical leadership experience.
• Strong knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485, and regulatory requirements.
• Experience with microbiological method validation, verification, transfer and investigations.
• Hands-on experience with core microbiology lab systems, aseptic techniques, EM, and culture media handling.
• Experience with OOS/OOT, NC, CAPA and root-cause investigations.
• Excellent communication, technical writing, organizational and problem-solving skills.
• Proficiency with Microsoft Office and LIMS or similar electronic systems (preferred).

Responsibilities

• Supervise daily QC Microbiology Lab operations and ensure timely, accurate testing.
• Coordinate testing of raw materials, in-process materials, finished products, validation samples, and stability studies.
• Manage Environmental Monitoring and Utilities Monitoring programs for controlled environments.
• Provide technical oversight of testing systems, EM, contamination control, and data integrity.
• Lead, coach, and evaluate laboratory personnel.
• Assign workload and prioritize tests to support manufacturing schedules.
• Ensure testing per procedures, GMP/GLP, GDP, and regulatory requirements.
• Review and approve data, records, protocols, and reports.
• Oversee external testing by contract labs and vendor communications.
• Maintain controlled documents and electronic data per GDP and data integrity requirements.
• Lead TMV, method transfer, and lifecycle management efforts.
• Support EMPQ, utility qualifications, and other microbiology validations.
• Collaborate with R&D/Manufacturing/Engineering/QA to support lifecycle activities.
• Lead CAPA and investigation activities and drive corrective actions.
• Prepare management reports and monitor performance metrics.
• Ensure equipment and software are qualified, calibrated, and maintained.

Skills

Leadership

GMP/GLP knowledge

Regulatory compliance

Quality data integrity

Problem solving

Communication

Technical writing

Biology/Microbiology expertise

Education

Bachelor's degree in Microbiology or related

Tools

LIMS

Microsoft Office

Job description

Integra LifeSciences Corporation seeks a Supervisor, QC Microbiology to provide leadership for the microbiology lab, ensuring compliant testing of materials and products. You will oversee environmental and utility monitoring, maintain data integrity, and drive continuous improvement in a regulated, FDA-inspected facility.

You will supervise personnel, coordinate testing across product stages, and collaborate with Manufacturing, QA, and R&D to support product lifecycle and regulatory readiness.