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Clinical Laboratory Manager
Bloomfield, CT

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Millstone Medical Outsourcing

Microbiology Supervisor

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Job Description

Microbiology Supervisor Millstone Medical Outsourcing - 3.0 Bloomfield, CT Job Details Full-time $70,000 - $80,000 a year 8 hours ago Benefits 401(k) matching Qualifications Biology Team development Hiring Supervising experience Bachelor's degree Microbiological analysis Process management Full Job Description Microbiology Supervisor - Millstone Medical Testing 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 8 plus 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
Leadership Competencies People Leadership:
Sets clear expectations, develops employees, and addresses performance issues effectively.
Accountability:
Maintains ownership for laboratory performance, quality, and operational commitments.
Communication:
Clearly communicates priorities, expectations, risks, and performance to laboratory personnel and management.
Decision-Making:
Makes timely operational decisions while appropriately escalating technical or quality concerns.
Organization:
Effectively manages competing priorities, staffing requirements, testing schedules, and laboratory resources.
Coaching & Development:
Builds employee capability through training, mentoring, feedback, and career development.
Collaboration:
Builds productive relationships across Laboratory, Quality, Operations, and other functions.
Problem Solving:
Identifies root causes and coordinates effective solutions to operational and laboratory problems. Join our team as we advance microbiological diagnostics through innovative leadership and rigorous scientific standards!
Pay:
$70,000.00 - $80,000.00 per year
Benefits:
401(k) matching
Experience:
Microbiology lab: 8 years (Required) Supervising/ team lead: 2 years (Required)
Work Location:
In person

Benefits

  • 401(k) Plans
  • Professional Development
  • Dental Insurance