Microbiology Manager
On-site · Bloomington, Indiana, United States
Job Summary
Microbiology Manager leads the Microbiology Department to ensure GMP compliance and drives quality improvements across products and processes. Responsible for environmental and critical utilities monitoring, evaluation of test methods against USP/regulatory standards, review/approval of reports and investigations, and ensuring GMP adherence across lab functions. Manages technicians/analysts, conducts hiring and performance reviews, supports manufacturing operations, and develops department budgets. Prepares and verifies SOPs, assists clients with interpretation of results, conducts lab quality assurance training, authors/ reviews EMPQ, studies, change control, and laboratory investigations, and participates in regulatory/client audits as SME. Offers day-one benefits and comprehensive compensation package.
Required Qualifications
- Bachelor’s degree in a physical science (Microbiology highly desired)
- Minimum 5 years experience in microbiology/QC with at least 2 years in a supervisory or management role
- Experience in QC Microbiology Laboratory supporting a pharmaceutical manufacturing facility
- Experience with environmental monitoring and critical utilities monitoring in GMP context
- Experience with test method evaluation against USP and regulatory standards
- Experience with audits (regulatory and client) as SME
- Strong computer proficiency (Microsoft Office, Outlook, LIMS, enterprise software such as 365, Veeva)
- Experience developing and implementing SOPs and change controls
- Ability to interpret results and communicate findings to clients/stakeholders
- Training in lab quality assurance procedures
- Ability to conduct performance reviews and develop staff
- Willingness for overtime; ability to sit for long hours and wear PPE
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