QC Microbiology Lab Lead – Impact & Compliance

Integra LifeSciences; Braintree (MA); On-site; USD 82,000 - 113,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) plan

Job summary

Integra LifeSciences is seeking a Supervisor for the Quality Control Microbiology Laboratory in Massachusetts. You will lead testing activities, ensure regulatory compliance, and drive data integrity across environmental monitoring, validation studies, and investigations.

The role requires extensive GMP/GLP experience, supervisory skills, and strong collaboration with Manufacturing, QA, and Engineering to support product release and continuous improvement.

Qualifications

• Minimum seven years GMP/GLP lab experience in a regulated industry.
• Minimum two years of supervisory or technical leadership experience.
• Knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485.
• Experience with microbiological method validation, verification, transfer and investigations.
• Experience with environmental monitoring, cleanroom operations, and culture media handling.
• Experience with OOS/OOT, NC, CAPA and root cause investigations.
• Strong data integrity and documentation practices.
• Proficiency with MS Office and LIMS.

Responsibilities

• Supervise daily operations of the Quality Control Microbiology Laboratory and ensure testing activities are completed accurately and on schedule.
• Oversee microbiological testing of raw materials, in-process materials, finished products, validation samples and stability samples.
• Manage Environmental Monitoring and Utilities Monitoring programs for controlled environments and cleanrooms.
• Provide technical oversight of microbiological testing systems and investigations.
• Lead and mentor laboratory personnel and manage workload priorities.
• Ensure testing complies with approved procedures, GMP/GLP, GDP, and regulatory requirements.
• Review and approve laboratory data, records, and reports.
• Coordinate external contract laboratory testing and data review.

Skills

Communication

Leadership

Problem-solving

Organizational skills

Technical writing

Education

Bachelor’s degree or higher in Microbiology/Biology/Biochemistry/Life Sciences

Tools

LIMS

Microsoft Office

Job description

Integra LifeSciences is seeking a Supervisor for the Quality Control Microbiology Laboratory in Massachusetts. You will lead testing activities, ensure regulatory compliance, and drive data integrity across environmental monitoring, validation studies, and investigations.

The role requires extensive GMP/GLP experience, supervisory skills, and strong collaboration with Manufacturing, QA, and Engineering to support product release and continuous improvement.