QC Manager, Microbiology

QC Microbiology Manager – Full-Time Direct Hire Location: Raleigh, NC Salary: $120,000‑$140,000/year Schedule: Monday‑Friday 8 am‑5 pm 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. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E‑Verify and will provide the federal government with your Form I‑9 information to confirm that you are authorized to work in the U.S. Kelly may use AI‑powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice. #J-18808-Ljbffr