Microbiology Supervisor

Millstone Medical Outsourcing is a leading provider of customized outsourcing solutions to the medical device industry. Millstone delivers expert post-manufacturing and aftermarket services for medical device manufacturers that foster quality, compliance, and business success. Millstone specializes in packaging, testing, and logistics services all with an unparalleled focus on quality.

Position Summary

The Microbiology Supervisor is responsible for the day-to-day leadership, coordination, and oversight of microbiology laboratory operations supporting medical device testing at Millstone Medical Testing. This position ensures microbiological testing is performed accurately, efficiently, safely, and in accordance with approved procedures, company quality requirements, and applicable regulatory and industry standards.

The Microbiology Supervisor provides direct supervision and development of microbiology laboratory personnel while maintaining accountability for laboratory workflow, staffing, testing schedules, documentation, equipment, quality, and compliance. The position works closely with Laboratory Management, Quality Assurance, Operations, and other cross-functional teams to resolve technical and operational issues and ensure laboratory commitments are met.

The Microbiology Supervisor is expected to provide strong people leadership while maintaining sufficient technical expertise to recognize and address microbiological testing issues, support investigations, and ensure consistent application of laboratory procedures and quality standards.

Key Responsibilities

Laboratory Operations & Workflow

• Supervise daily microbiology laboratory activities to ensure testing is completed accurately and within established schedules.
• Coordinate staffing, workload, priorities, and laboratory resources based on testing requirements and business needs.
• Monitor laboratory workflow and identify potential capacity, scheduling, or resource constraints.
• Ensure samples, media, reagents, equipment, and other laboratory resources are available to support testing activities.
• Coordinate with other laboratory functions to ensure efficient sample flow and timely completion of testing.
• Monitor turnaround times and communicate potential delays or operational concerns to laboratory leadership.
• Ensure laboratory work areas remain organized, clean, inspection-ready, and compliant with applicable safety and quality requirements.
• Support implementation of laboratory operational goals, metrics, and performance expectations.

People Leadership & Development

• Directly supervise microbiology laboratory personnel and provide clear expectations regarding performance, quality, productivity, safety, and professional conduct.
• Conduct regular performance discussions, provide feedback, and address performance issues in accordance with company policies.
• Participate in hiring, interviewing, onboarding, and personnel selection activities as needed.
• Develop employee training plans and ensure personnel receive required training and maintain appropriate qualifications.
• Monitor employee competency and identify opportunities for technical and professional development.
• Provide coaching, mentoring, and career-development support to microbiologists and laboratory technicians.
• Promote teamwork, accountability, communication, and a culture of quality.
• Recognize strong performance and address performance gaps promptly and appropriately.
• Support succession planning and development of future technical and laboratory leaders.

Microbiological Testing Oversight

• Provide operational oversight of microbiological testing supporting medical device testing.
• Ensure testing is performed according to approved SOPs, test methods, protocols, specifications, and applicable standards.
• Monitor execution of applicable testing activities, which may include:

Bioburden testing

Sterility testing

Microbial enumeration

Environmental monitoring

Growth promotion testing

Media suitability testing

Microbial identification

Other microbiological testing as applicable

• Ensure analysts are appropriately trained and qualified before performing assigned testing.
• Review laboratory results and documentation as required by established procedures.
• Ensure atypical, unexpected, or potentially invalid results are appropriately identified and escalated.
• Provide technical support to laboratory personnel when issues arise and engage Senior, Lead, or Principal Microbiologists as appropriate.

Quality & Compliance

• Ensure laboratory activities comply with the Millstone Medical Testing quality system and applicable regulatory and industry requirements.
• Reinforce adherence to Good Documentation Practices (GDP), data integrity principles, laboratory safety requirements, and approved procedures.
• Support compliance with applicable standards, including ISO 13485 and ISO/IEC 17025, as applicable to laboratory activities.
• Monitor laboratory documentation for completeness, accuracy, and compliance.
• Ensure deviations, nonconformances, and other quality events are promptly communicated and appropriately managed.
• Participate in internal and external audits, client audits, and regulatory inspections.
• Support development and implementation of corrective and preventive actions.
• Identify potential compliance risks and escalate concerns to Quality and laboratory leadership.
• Ensure laboratory personnel understand and consistently follow applicable quality requirements.

Investigations & Troubleshooting

• Lead or support investigations involving laboratory deviations, nonconformances, contamination events, atypical results, equipment issues, and other laboratory problems.
• Coordinate appropriate initial assessments and containment activities.
• Work with microbiology technical experts and Quality personnel to identify root causes and develop corrective actions.
• Ensure investigation activities are completed within established timelines.
• Monitor effectiveness of corrective actions and identify opportunities to prevent recurrence.
• Escalate complex scientific or technical issues to Senior, Lead, or Principal Microbiologists as appropriate.

Equipment & Laboratory Resources

• Ensure microbiology laboratory equipment is available, maintained, calibrated, and qualified as required.
• Monitor equipment performance and coordinate response to equipment failures or abnormalities.
• Ensure laboratory personnel follow applicable equipment operating and maintenance procedures.
• Support equipment qualification, installation, replacement, and implementation activities.
• Ensure appropriate controls are in place for laboratory reagents, media, supplies, and other critical materials.
• Monitor inventory levels and work with appropriate personnel to prevent material shortages or testing interruptions.

Training & Competency

• Ensure microbiology personnel complete required training and maintain current qualifications.
• Coordinate training on SOPs, test methods, laboratory equipment, safety, and quality-system requirements.
• Evaluate training effectiveness and employee competency.
• Work with Senior, Lead, and Principal Microbiologists to establish technical training and development plans.
• Ensure changes to methods, equipment, procedures, or quality requirements are incorporated into appropriate training programs.
• Maintain appropriate training and qualification records.

Process Improvement

• Identify opportunities to improve laboratory efficiency, quality, capacity, and employee effectiveness.
• Monitor laboratory performance metrics and identify trends requiring action.
• Lead or participate in continuous improvement initiatives.
• Work with technical leadership to improve testing workflows, laboratory methods, and operational processes.
• Support implementation of new equipment, technologies, methods, and laboratory capabilities.
• Encourage employees to identify and communicate opportunities for improvement.

Cross-Functional Collaboration

• Collaborate with Quality Assurance on deviations, CAPAs, audits, investigations, and quality-system activities.
• Work with Laboratory Management to establish priorities, staffing plans, resource requirements, and operational goals.
• Partner with Project Management and Operations to support testing schedules and client commitments.
• Collaborate with Senior, Lead, and Principal Microbiologists on technical issues and laboratory capability development.
• Communicate laboratory status, risks, staffing needs, and operational concerns to management.
• Support client-facing activities when appropriate.

Qualifications

Education

• Bachelor’s degree in microbiology, Biology, Medical Technology, or a related life science required.
• Master’s degree in microbiology, Biology, or a related discipline preferred.
• Equivalent combination of education and relevant laboratory experience may be considered where appropriate.

Experience

• 5–8 years of microbiology laboratory experience, with experience in a regulated laboratory environment.
• At least 2 years of supervisory, team-lead, or laboratory leadership experience preferred.
• Experience in a medical device, pharmaceutical, biotechnology, contract laboratory, or other regulated environment strongly preferred.
• Demonstrated experience with microbiological testing and laboratory quality systems.
• Experience with employee training, performance management, scheduling, or laboratory resource planning preferred.

Technical Skills

• Strong understanding of microbiological principles and laboratory practices.
• Proficiency in aseptic technique and contamination-control practices.
• Working knowledge of microbiological testing methods applicable to medical device testing.
• Knowledge of microbiological media preparation, growth promotion, and suitability testing.
• Ability to recognize and appropriately escalate technical or scientific issues.
• Working knowledge of laboratory equipment and instrumentation.
• Strong understanding of GDP, data integrity, and laboratory documentation requirements.
• Ability to interpret SOPs, test methods, protocols, and applicable standards.
• Proficiency with LIMS and electronic laboratory systems preferred.
• Strong computer, organizational, and technical documentation skills.

Preferred Technical Experience

Experience with one or more of the following is preferred:

• Bioburden testing
• Sterility testing
• Microbial enumeration
• Environmental monitoring
• Microbial identification
• Growth promotion testing
• Media suitability testing
• Contamination investigations
• Method verification or validation
• Medical device microbiology
• ISO 13485
• ISO/IEC 17025
• GLP and GDP requirements
• LIMS or electronic laboratory systems

At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we offer a Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.

TOTAL REWARDS BENEFITS PROGRAM:

• Medical - Starting on the 1st day of employment
• Dental - Starting on the 1st day of employment
• Vision - Starting on the 1st day of employment
• Supplemental Benefits - Life, Disability, Critical Illness
• Paid Time Off
• Tuition Reimbursement
• Career Pathing
• 401(k)
• 401(k) matching

To learn more about Millstone Medical, please visit us online at www.millstonemedical.com.

ADDITIONAL INFORMATION:

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.