Quality Control — Microbiology The Microbiologist will be responsible for overseeing environmental monitoring, sterility testing, and microbial identification processes to ensure compliance with USP 795, 797, and 800, as well as FDA and state board regulations. This role plays a critical part in maintaining aseptic conditions and ensuring the microbiological integrity of compounded sterile preparations.
Key Responsibilities:- Perform routine and non-routine environmental monitoring of ISO-classified cleanrooms
- Conduct active air, passive air, surface, and personal sampling during and after operations
- Analyze data trends and ensure results are within facility-specific alert and action levels
- Ensure proper sampling coverage of critical and non-critical zones
- Test purified water systems, surfaces, and personnel for microbial contamination
- Conduct bioburden testing of raw materials and components prior to compounding
- Maintain sample traceability and data integrity from collection through result reporting
- Coordinate sterility testing for CSPs using membrane filtration or direct inoculation
- Monitor incubation and growth observations according to USP 71 Document results and escalate any abnormal findings per established protocols
- Oversee bacterial endotoxin testing (BET) using LAL methods (gel-clot, chromogenic, turbidimetric)
- Ensure test methods meet compendial and product-specific requirements
- Investigate test failures and assess impact on product quality and safety
- Identify recovered organisms using Gram staining and advanced ID tools
- Track trends in cleanroom isolates and product contamination data
- Prepare monthly and quarterly microbiological trending reports
- Lead microbiology-related investigations for out-of-specification results or EM excursions
- Perform root cause analysis and implement CAPs in collaboration with QAEnsure accurate, complete, and timely investigation documentation
- Observe and evaluate aseptic practices during media fills and daily operations
- Assist with training, qualification, and periodic requalification of cleanroom personnel
- Review gowning footage and aseptic practices for compliance with SOPsOversee calibration and maintenance of EM and microbiology lab equipment (e.g., air sampler, endotoxin readers)
- Maintain equipment logs, service records, and calibration certificates
- Draft, revise, and review SOPs, protocols, and microbiological test methods
- Ensure alignment with USP chapters, FDA guidance, and internal procedures
- Support regular SOP review cycles and change control processes
- Partner with QA and Production on cleanroom control and contamination risk management
- Participate in cross-functional meetings, audits, and projects
- Provide microbiological input for risk assessments and change controls
- Prepare and present microbiology data during internal and external audits
- Support regulatory inspections with required documentation
- Maintain an audit-ready state through continuous compliance
- Physical Demands
- Ability to stand for long periods of time during cleanroom monitoring or gowning activities
- Fine motor skills to handle small lab tools, pipettes, swabs, and other microbiological equipment
- Ability to lift and carry equipment or testing materials weighing up to 25 pounds
- Good visual acuity (with or without corrective lenses) for microscopic analysis and detailed data review
- Capability to work in controlled environments (temperature and humidity controlled cleanrooms)
- Occasional sitting, bending, crouching, or reaching as required by cleanroom tasks
Required Qualifications:- Bachelor's Degree in Microbiology, Biology, or related field
- Minimum 2 years of experience in microbiological testing in a regulated pharmaceutical, biotech, or compounding environment
- Working knowledge of USP chapters: 795, 797, 71, 85, 1116 Familiarity with aseptic technique and cleanroom practices in GMP/GLP settings
- Experience with environmental monitoring, bioburden testing, and sterility testing protocols
- Strong understanding of cGMPs, FDA guidelines, and quality documentation practices
- Proficiency in Google Suite and LIMS or quality documentation systems
Benefits:
Company-paid health, dental, and vision insurance.401(k) plan with employer match.
Paid Holidays, Floating Holidays, and Paid Time Off (PTO).Tuition and Certification Reimbursement Programs.
RTD EcoPass for public transportation.
Opportunities for professional growth and development.
Equal Opportunity EmployerVPI Compounding Pharmacy is an Equal Employment Opportunity (EEO) employer. We are committed to providing equal opportunity for all qualified individuals employed by or seeking employment with VPI, regardless of race, color, creed, religion, sex, sexual preference, national origin, age, marital status, veteran status, or non-job-related disabilities. This policy extends to all areas of employment, including recruitment, job assignment, promotion, and other terms of employment.
