Critical Prerequisites for the Position

• Bachelor's degree or higher in Microbiology, Biology, Biochemistry, Life Sciences, or a related scientific 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 Quality Management System Regulation (QMSR), 21 CFR Part 820, ISO 13485, and applicable quality-system requirements.
• Experience with microbiological method validation, verification, transfer and investigations.
• Extensive hands-on experience with core microbiology laboratory systems, aseptic techniques, environmental monitoring, and culture media preparation/handling within a regulated cGMP environment.
• Demonstrated experience managing environmental monitoring programs, cleanroom operations, utility monitoring, and microbiological testing activities.
• Experience with OOS/OOT, NC, CAPA and root cause investigations.
• Strong understanding of laboratory data integrity principles and documentation practices.
• Excellent communication, technical writing, organizational, leadership, and problem-solving skills.
• Proficiency with Microsoft Office applications and laboratory information management systems (LIMS) or equivalent electronic systems preferred.

Position Summary Description

The Supervisor, QC Microbiology Laboratory provides technical and operational leadership of the QC Microbiology Laboratory. Responsible for microbiological testing supporting in-process and finished product testing, environmental monitoring, utility monitoring, cleanroom qualification and microbiological validation activities. Ensures compliant laboratory operations, data integrity, testing execution, inventory control, personnel development and inspection readiness while partnering with Manufacturing, QA, Engineering, Product Development, and external laboratories. The role ensures compliance with applicable FDA regulations, ISO 13485 requirements, GMP/GLP standards, and company quality system procedures while fostering a culture of quality, compliance, and continuous improvement

Essential Duties and Responsibilities

• Supervise daily operations of the Quality Control Microbiology Laboratory and ensure testing activities are completed accurately and on schedule.
• Oversee and coordinate microbiological testing of raw materials, in-process materials, finished products, validation samples, stability samples, and special studies in support of manufacturing operations and product release.
• Manage and coordinate Environmental Monitoring (EM) and Utilities Monitoring programs for controlled manufacturing environments, cleanrooms, USP Purified Water systems, and compressed gas systems.
• Provide technical oversight of microbiological testing systems, environmental monitoring programs, contamination control activities, utility monitoring programs, and laboratory investigations.
• Provide leadership, coaching, mentoring, and performance management for laboratory personnel.
• Assign laboratory workload and establish testing priorities to support manufacturing schedules and business objectives.
• Ensure laboratory testing is performed in accordance with approved procedures, specifications, GMP, GLP, GDP, and applicable regulatory requirements.
• Review, approve, and ensure the accuracy of laboratory data, testing records, logbooks, protocols, reports, and other quality records.
• Manage microbiological testing performed by qualified external contract laboratories, including sample submission, testing requirements, data review, results review, and vendor communications.
• Maintain laboratory documentation, logbooks, controlled records, and electronic data in accordance with GDP and data integrity requirements.
• Lead or support microbiological Test Method Validation (TMV), method transfer, implementation, lifecycle management, and continuous improvement activities.
• Lead or support Environmental Monitoring Performance Qualifications (EMPQ), utility qualifications, and other microbiological validation activities.
• Support process validation, cleaning validation, equipment qualification, product transfer, and product development activities requiring microbiology laboratory support.
• Collaborate with Research & Development, Product Development, Manufacturing, Engineering, and Quality Assurance to support product lifecycle activities.
• Lead or support Laboratory Error, Out-of-Specification (OOS), Out-of-Trend (OOT), Nonconformance (NC), CAPA, and data integrity investigations and associated corrective actions.
• Prepare, review, analyze, and communicate laboratory performance data, environmental monitoring trends, utility monitoring trends, product monitoring data, quality metrics, and management reports.
• Ensure laboratory equipment, computerized systems, and associated software are qualified, calibrated, maintained, secured, and operating within validated parameters in accordance with data integrity requirements.
• Manage and procure laboratory materials including media, reagents, reference cultures, consumables, laboratory supplies, and PPE.
• Develop, review, revise, and approve laboratory procedures, test methods, work instructions, forms, specifications, and related controlled documents.
• Participate in FDA inspections, ISO certification audits, surveillance audits, internal audits, customer audits, and regulatory inspections as a subject matter expert.
• Ensure laboratory personnel complete required training and maintain competency for assigned responsibilities.
• Identify and implement continuous improvement initiatives to improve laboratory efficiency, compliance, contamination control, data integrity, and overall laboratory performance.
• Maintain compliance with company safety policies, hazardous material handling procedures, biosafety requirements, and environmental requirements.
• Perform additional duties and special projects as assigned.

Supervisory Responsibilities

• Directly supervises Quality Control Microbiology Laboratory personnel.
• Identify resource needs; recruit, onboard, schedule, and train personnel.
• Performance evaluations, coaching, corrective actions, and employee development.
• Manage laboratory priorities and resource allocations to meet operational objectives.
• Provide cross-functional technical leadership.

Salary Pay Range:

$81,650.00 - $112,700.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

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