Lab Supervisor

Zimmer GmbH; Braintree (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical technology company is seeking a Laboratory Supervisor responsible for directing all laboratory activities and ensuring regulatory compliance. The ideal candidate will have a strong background in microbiology and sterilization technology, along with proven supervisory experience. You will enhance laboratory operations by overseeing testing processes and compliance with good manufacturing practices in a fast-paced environment.

Qualifications

• 5-7 years of industry/lab experience required.
• Supervision experience preferred.

Responsibilities

• Supervise laboratory operations ensuring compliance with GMP.
• Prepare and review testing results for product release.
• Conduct audits of vendors and laboratory compliance.

Skills

Clean Room Standards

Microbiology Knowledge

Sterilization Technology

Problem Solving

Communication Skills

Education

B.S. in Microbiology, Biology, Medical Technology

Job description

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

What You Can Expect

This position is responsible for leading/directing/scheduling all laboratory activities for either the Environmental Services Laboratory or the Microbiology Services Laboratory.
Responsibilities include:

• Scheduling the daily laboratory operations to ensure testing, results, procedures, and documentation are in compliance with current GMP.
• Preparing/Coordinating/Reviewing the testing results for product release, FDA submissions, foreign country product registrations, and compliance to current GMPs.
• Ensuring that all laboratory equipment, calibrations, procedures and training are properly maintained and compliant.

How You'll Create Impact

• Schedule and supervise the daily operations of the laboratory to ensure testing, test results and documentation are in compliance with current procedures.
• Provide supervision, coordination, and assistance in conducting environmental assessments, environmental qualifications, validations and special projects as they occur.
• Prepare/Review/Approve departmental documentation (Zimmer Work Instructions, test protocols, validation documents, technical reports, etc.).
• Collect, enumerate, analyze and report laboratory data for qualifications, validations, trending and special projects.
• Assist Manufacturing in troubleshooting issues in environmentally controlled areas, product bioburden, or sterilization.
• Provide assistance and technical knowledge in clean room design, behavior, and sanitization.
• Conduct audits of vendors, contract laboratories and Zimmer facilities for compliance with applicable procedures and techniques.
• Assess and implement (if applicable) new technologies that improve/automate laboratory or manufacturing processes.
• Represents Zimmer on AAMI Standards committees.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

What Makes You Stand Out

• Ability to make accept/reject decisions based on clearly defined procedures and knowledge of clean room, microbiology, and sterilization technology and standards.
• Creative and innovative problem solving skills.
• Must have a basic knowledge of all Sterilization Technology related fields. These areas include clean rooms, sterilization of product, product packaging, water purification, and good manufacturing practices.
• Must have prior experience with validation of industrial sterilization processes.
• Must have a thorough knowledge of Medical Device GMPs, industrial sterilization guidelines, and ISO standards.
• Must possess excellent written and oral communication skills.
• Experience in GMP auditing and preparation of procedures is desirable.

Your Background

• B.S. in Microbiology, Biology, Medical Technology, or other related field.
• 5-7 years of industry/lab experience required.
• Supervision experience preferred.

Travel Expectations

10%

Expected Compensation Range

$80,000-$100,000

EOE/M/F/Vet/Disability