QC Manager, Microbiology

Job Description

Job Description

QC Microbiology Manager – Full-Time Direct Hire 
Location: Raleigh NC
Salary: $120,000-$140,000/year
Schedule: Monday-Friday 8am-5pm

Seeking an experienced QC Microbiology Manager to oversee microbiological operations within a regulated pharmaceutical manufacturing environment. This leadership role is responsible for ensuring compliance with GMP and global regulatory standards while managing microbiological testing, contamination control programs, laboratory investigations, and daily laboratory operations.

Key Responsibilities:
• Lead and manage all QC Microbiology laboratory operations, including oversight of a team of approximately 12–15 analysts
• Oversee microbiological testing for raw materials, in-process samples, finished products, stability samples, packaging components, and environmental monitoring programs
• Manage testing activities including sterility, bioburden, endotoxin, particulate matter, growth promotion, personnel monitoring, and environmental monitoring
• Ensure timely, accurate, and compliant reporting of microbiological test results and laboratory documentation
• Lead investigations involving deviations, out-of-specification results, environmental excursions, sterility failures, and atypical findings, including root cause analysis and CAPA implementation
• Partner cross-functionally with Manufacturing, Sterility Assurance, Engineering, Validation, and Quality teams to support contamination control strategies and production schedules
• Review and approve SOPs, specifications, validation protocols, test methods, and change controls impacting microbiology operations
• Maintain audit readiness and support internal and external regulatory inspections
• Conduct trend analysis of microbiological and environmental monitoring data to identify potential risks or quality concerns
• Drive continuous improvement initiatives focused on laboratory efficiency, compliance, and method robustness
• Provide technical leadership, mentorship, and training to microbiology staff while ensuring training compliance and competency standards are maintained
• Utilize LIMS and other quality systems to ensure data integrity and regulatory compliance

Qualifications:
• Bachelor’s degree in Microbiology or related scientific discipline (advanced degree preferred)
• 10+ years of microbiology laboratory experience within a regulated pharmaceutical manufacturing environment
• 3+ years of leadership experience managing microbiology operations and laboratory personnel
• Strong knowledge of GMP, FDA, USP, and global regulatory requirements
• Experience supporting aseptic manufacturing, terminal sterilization, contamination control, and environmental monitoring programs
• Proficiency with LIMS, QMS, and laboratory investigation processes
• Strong leadership, communication, organizational, and problem-solving skills

Additional Details:
• Full-time direct hire opportunity
• Fully onsite role
• No relocation assistance offered

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

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