Quality Control Microbiology

Quality Control — MicrobiologyThe Microbiologist will be responsible for overseeing environmental monitoring, sterility testing, and microbial identification processes to ensure compliance with USP 795, 797, 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 ResponsibilitiesPerform routine and non-routine environmental monitoring of ISO-classified cleanroomsConduct active air, passive air, surface, and personal sampling during and after operationsAnalyze data trends and ensure results are within facility-specific alert and action levelsEnsure proper sampling coverage of critical and non-critical zonesTest purified water systems, surfaces, and personnel for microbial contaminationConduct bioburden testing of raw materials and components prior to compoundingMaintain sample traceability and data integrity from collection through result reportingCoordinate sterility testing for CSPs using membrane filtration or direct inoculationMonitor incubation and growth observations according to USP 71Document results and escalate any abnormal findings per established protocolsOversee bacterial endotoxin testing (BET) using LAL methods (gel-clot, chromogenic, turbidimetric)Ensure test methods meet compendial and product-specific requirementsInvestigate test failures and assess impact on product quality and safetyIdentify recovered organisms using Gram staining and advanced ID toolsTrack trends in cleanroom isolates and product contamination dataPrepare monthly and quarterly microbiological trending reportsLead microbiology-related investigations for out-of-specification results or EM excursionsPerform root cause analysis and implement CAPs in collaboration with QAObserve and evaluate aseptic practices during media fills and daily operationsAssist with training, qualification, and periodic requalification of cleanroom personnelReview gowning footage and aseptic practices for compliance with SOPsOversee calibration and maintenance of EM and microbiology lab equipmentMaintain equipment logs, service records, and calibration certificatesDraft, revise, and review SOPs, protocols, and microbiological test methodsPartner with QA and Production on cleanroom control and contamination risk managementPrepare and present microbiology data during internal and external auditsSupport regulatory inspections with required documentationPhysical DemandsAbility to stand for long periods of time during cleanroom monitoring or gowning activitiesFine motor skills to handle small lab tools, pipettes, swabs, and other microbiological equipmentAbility to lift and carry equipment or testing materials weighing up to 25 poundsGood visual acuity (with or without corrective lenses) for microscopic analysis and detailed data reviewCapability to work in controlled environments (temperature and humidity controlled cleanrooms)Occasional sitting, bending, crouching, or reaching as required by cleanroom tasksRequired QualificationsBachelor's Degree in Microbiology, Biology, or related fieldMinimum 2 years of experience in microbiological testing in a regulated pharmaceutical, biotech, or compounding environmentWorking knowledge of USP chapters: 795, 797, 71, 85, 1116Familiarity with aseptic technique and cleanroom practices in GMP/GLP settingsExperience with environmental monitoring, bioburden testing, and sterility testing protocolsStrong understanding of cGMPs, FDA guidelines, and quality documentation practicesProficiency in Google Suite and LIMS or quality documentation systemsBenefitsCompany-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.