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Microbiology Supervisor I
Perrigo Company plc. Oversee daily microbiology laboratory activities, testing, and personnel to support operations and manufacturing needs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in microbiology laboratory management, ensuring compliance with cGMP requirements and FDA regulations while leading a team of Microbiologists. Proficient in conducting risk assessments, managing quality investigations, and authoring SOPs and controlled documents.
Highest-signal resume keywords
Microbiology Laboratory ManagementCGMP ComplianceQuality InvestigationsSOP AuthoringRisk Assessments
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Microbial Risk AssessmentsData IntegrityQuality ControlEnvironmental MonitoringCAPA ImplementationTesting of Raw MaterialsPharmaceutical Product TestingData ReviewSpecification DevelopmentControlled Document Management
Soft Skills
Team LeadershipCoachingTraining OversightCommunicationProblem Solving
Certifications & Qualifications
Bachelor’s Degree in BiologyBachelor’s Degree in MicrobiologyNYS Board of Pharmacy Permit
Industry Keywords
CGMP RequirementsFDA RegulationsQuality SystemsSOPsLaboratory SafetyPharmaceutical EnvironmentInspection ReadinessContinuous ImprovementQuality MetricsAtypical Results
About the role
Key responsibilities & impact- Oversee daily microbiology laboratory activities, testing, and personnel to support operations and manufacturing needs
- Lead a team of Microbiologists testing topical, nasal spray, and suppository pharmaceutical products
- Implement and monitor cGMP requirements for QC laboratory data, including data integrity and controls
- Manage daily microbiology lab activities, including work scheduling, data review and release, and safety requirements
- Supervise, coach, evaluate, and oversee training of Microbiologists
- Ensure laboratory activities comply with cGMP requirements, FDA regulations, approved procedures, and internal SOPs
- Provide microbiology support to operations by addressing quality concerns, conducting risk assessments, and escalating issues
- Perform microbial risk assessments for new raw materials and formulations to establish appropriate specifications
- Author, revise, review, and approve SOPs, test methods, specifications, and controlled documents
- Author investigations involving OOS or atypical results, environmental monitoring excursions, and other microbiological quality events
- Design and implement CAPAs
- Monitor compliance trends and identify continuous improvement opportunities
- Act as microbiology subject matter expert during inspections and audits, maintaining inspection readiness and implementing remediation activities
- Track and trend laboratory performance and safety metrics and implement necessary changes
Requirements
What you’ll need- Bachelor’s Degree in Biology, Microbiology or related discipline
- Three or more years of experience in a GMP laboratory environment
- One or more years of previous supervisory experience; candidates without previous supervisory experience may be considered if they meet all other qualifications and possess considerable laboratory knowledge in a pharmaceutical environment
- Knowledge of cGMP requirements, FDA regulations, internal quality systems, approved procedures, and SOPs
- Ability to oversee testing of raw materials, products, water, and environmental monitoring
- Ability to serve as registered supervisor for microbiology lab in NYS Board of Pharmacy permit and maintain renewal
- Experience with data integrity, data controls, quality investigations, OOS and atypical results, environmental monitoring excursions, CAPAs, risk assessments, SOPs, test methods, specifications, and controlled documents
- Ability to support inspections, customer audits, and internal audits
- All application materials, including resumes and CVs, must be submitted in English
Benefits
Comp & perks- Competitive compensation
- Benefits tailored to supporting employees and their families
- Career development opportunities