Laboratory Supervisor, MQSA

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Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

People Leader

All Job Posting Locations:

Warsaw, Indiana, United States of America

Job Description:

Depuy Synthes a member of the Johnson & Johnson Family of Companies is currently recruiting for a Laboratory Supervisor, Microbiology Quality & Sterility Assurance! This position will be located in Warsaw, IN.

Position Summary

The Laboratory Supervisor, Microbiology & Analytical Sciences is responsible for the leadership, technical oversight, compliance, and continuous improvement of an ISO 13485-compliant microbiology and chemistry laboratory supporting medical device development, manufacturing, and validation activities. The role oversees laboratory personnel, testing operations, equipment qualification and maintenance, data integrity, method execution, and regulatory compliance.

The laboratory supports environmental monitoring, microbiological testing, cleaning validations, sterilization validations, water quality assessments, and microbial identification programs. The Laboratory Supervisor serves as a subject matter expert in microbiology, contamination control, reusable device reprocessing validation, and laboratory quality systems while ensuring compliance with applicable regulatory standards and industry guidance.

Key Responsibilities

Laboratory Operations & Personnel Management

Lead, supervise, train, and develop microbiology and analytical laboratory personnel.

Establish performance objectives and ensure execution of laboratory goals, timelines, and quality requirements.

Manage laboratory workload, scheduling, resource allocation, and staffing plans.

Foster a culture of quality, compliance, safety, scientific rigor, and continuous improvement.

Support internal and external audits and regulatory inspections.

Microbiology Laboratory Oversight

Direct and oversee execution of:

Environmental monitoring programs Viable air monitoring

Non-viable particulate monitoring

Surface monitoring

Personnel monitoring

Compressed gas monitoring

Product microbiological testing Bioburden testing

Sterility testing

Microbial limits testing

Water and utility testing Microbial water testing

Endotoxin testing

Total Organic Carbon (TOC) testing

Compressed air quality testing

Microbial characterization MALDI-TOF microbial identification

Gram staining

Culture characterization

Investigation support

Microbiological support activities Media preparation

Media qualification

Growth promotion testing

Culture maintenance and preservation

Validation & Technical Leadership

Provide technical leadership for:

Reusable medical device cleaning validation studies

Cleaning efficacy assessments

Disinfection validation studies

Steam sterilization validation and requalification

Microbiological method validation and verification

Environmental monitoring program design and risk assessments

Cleanroom qualification and contamination control strategy development

Investigation of microbiological excursions, out-of-specification results, and adverse trends

CAPA development and effectiveness verification

Equipment Qualification & Lifecycle Management

Manage qualification, maintenance, calibration, and lifecycle activities for laboratory equipment including:

MALDI-TOF systems

Particle counters

Air sampling equipment

TOC analyzers

Endotoxin testing systems

Incubators

Autoclaves

Biosafety cabinets

Refrigerators and freezers

Laboratory water systems

Environmental monitoring equipment

Analytical instrumentation supporting microbiological testing

Responsible for:

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Requalification activities

Preventive maintenance programs

Calibration programs

Equipment change control

Quality Systems & Compliance

Ensure laboratory activities comply with ISO 13485 requirements.

Develop, review, and approve SOPs, protocols, reports, work instructions, and technical documentation.

Maintain data integrity and documentation practices in accordance with GMP expectations.

Support supplier qualification activities and laboratory audits.

Manage laboratory investigations, deviations, nonconformances, and CAPAs.

Drive continuous improvement initiatives focused on laboratory excellence and operational efficiency.

Required Qualifications

Education

Bachelor's degree in Microbiology, Biology, Biochemistry, Chemistry, Biomedical Sciences, or related scientific discipline.

Master's degree preferred.

Experience

Minimum 8 years of microbiology laboratory experience in the medical device, pharmaceutical, biotechnology, or regulated healthcare industry.

Minimum 3 years of supervisory or laboratory management experience.

Demonstrated experience managing an ISO 13485-compliant laboratory.

Experience supporting FDA, Notified Body, customer, and internal audits.

Technical Expertise

Demonstrated expertise in:

Environmental monitoring programs

Bioburden testing

Sterility testing

Endotoxin testing

Microbial water testing

TOC testing

Compressed air monitoring

Microbial identification using MALDI-TOF technology

Gram stain techniques

Media preparation and qualification

Cleaning validation

Disinfection validation

Steam sterilization validation

Laboratory investigations and CAPA management

Contamination control programs

Risk assessment methodologies

Equipment Qualification Experience

Hands-on experience performing and approving:

IQ/OQ/PQ protocols

Equipment validation reports

Method validations

Requalification programs

Calibration and maintenance programs

Regulatory & Standards Knowledge

Strong working knowledge of:

ISO 13485 – Medical Devices Quality Management Systems

ISO 14644 – Cleanrooms and Associated Controlled Environments

ISO 11137 – Radiation Sterilization of Health Care Products

ISO 17664 – Processing of Health Care Products/Reprocessing Instructions

AAMI ST98 – Cleaning Validation of Health Care Products

Applicable ASTM standards related to medical device cleaning validation and reusable device processing

USP microbiological methodologies

FDA Quality System Regulation and medical device guidance documents

GMP principles and laboratory controls

Preferred Qualifications

Experience supporting new product development programs.

Experience designing and qualifying cleanrooms, water systems, and compressed gas systems.

Experience with Laboratory Information Management Systems (LIMS).

Certified ISO 13485 Lead Auditor or Internal Auditor.

Participation in AAMI, ASTM, PDA, or industry working groups.

Experience supporting global manufacturing operations.

Key Competencies

Laboratory Leadership

Technical Decision Making

People Development

Problem Solving & Root Cause Analysis

Cross-Functional Collaboration

Regulatory Compliance

Risk Management

Scientific Writing

Project Management

Continuous Improvement

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation,  external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills: