QC Analytics Lab Supervisor - Lead, Ensure Compliance

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

Benefits offered by this job

Medical

Dental

Vision

Life insurance

Disability insurance

401(k)

Job summary

Integra LifeSciences Corporation seeks a Supervisor to lead the Quality Control Analytical Laboratory, directing analytical testing across raw materials, in-process, and finished products to ensure timely release and regulatory compliance.

You will drive method validation, instrument qualification, data integrity and cross-functional collaboration with Manufacturing, QA, R&D, and external labs to support product development and lifecycle programs.

Qualifications

• Bachelor's degree or higher in Chemistry, Biochemistry, Biology, Engineering, or a related scientific or engineering discipline.
• Minimum seven (7) years of GMP/GLP laboratory experience within the medical device, pharmaceutical, biotechnology, or other FDA-regulated industry.
• Minimum two (2) years of supervisory or technical leadership experience.
• Strong working knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485, and applicable quality-system requirements.
• Experience with analytical method validation, verification, transfer and investigations.

Responsibilities

• Supervise daily operations of the Quality Control Analytical Laboratory and ensure testing activities are completed accurately and on schedule.
• Oversee and coordinate analytical testing of raw materials, in-process materials, finished products, validation samples, stability samples, and special studies in support of manufacturing operations and product release.
• Provide technical oversight of analytical chemistry and mechanical testing systems, including method performance, instrument suitability, troubleshooting, and data review activities.
• Provide leadership, coaching, mentoring, and performance management for laboratory personnel.
• Assign laboratory workload and establish testing priorities to support manufacturing schedules and business objectives.

Skills

Leadership

Technical writing

Problem solving

Communication

Cross-functional collaboration

Education

Bachelor's degree in Chemistry/Biochemistry/Biology or Engineering

Tools

LIMS

Analytical instrumentation

Job description

Integra LifeSciences Corporation seeks a Supervisor to lead the Quality Control Analytical Laboratory, directing analytical testing across raw materials, in-process, and finished products to ensure timely release and regulatory compliance.

You will drive method validation, instrument qualification, data integrity and cross-functional collaboration with Manufacturing, QA, R&D, and external labs to support product development and lifecycle programs.