Job Description
Job Description
Salary : $26- $30 per hour. DOE
Quality Control Microbiology
Department : Quality
Location : Centennial, CO, 80112
Employment Type : Full-Time.
Compensation : $26-30 per hour
Job Summary
The Microbiologist will be responsible for overseeing environmental monitoring, sterility testing, and microbial identification processes to ensure compliance with USP
, and
, 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
Environmental Monitoring :
- Perform routine and non-routine and non-viable EM 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.
Microbiological Testing of Utilities and Materials :
Test 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 reportingSterility Assurance and USP
Testing :
Coordinate sterility testing for CSPs using membrane filtration or direct inoculationMonitor incubation and growth observations according to USPDocument results and escalate any abnormal findings per established protocolsEndotoxin Testing (USP
) :
Oversee 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 safety.Microbial Identification and Trending :
Identify recovered organisms using Gram staining and advanced ID toolsTrack trends in cleanroom isolates and product contamination dataPrepare monthly and quarterly microbiological trending reports (Data gave me this frequency - can change to reflect our needs - or leave as is)OOS and Excursion Investigations :
Lead microbiology-related investigations for out-of-specification results or EM excursionsPerform root cause analysis and implement CAPs in collaboration with QAEnsure accurate, complete, and timely investigation documentationAseptic Technique and Gowning Qualification Support :
Observe 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 SOPsLaboratory Equipment Maintenance and Qualification :
Oversee calibration and maintenance of EM and microbiology lab equipment (e.g., air sampler, endotoxin readers)Maintain equipment logs, service records, and calibration certificatesEnsure compliance with cGMPs and lab SOPsSOP Management and Document Control :
Draft, revise, and review SOPs, protocols, and microbiological test methodsEnsure alignment with USP chapters, FDA guidance, and internal proceduresSupport regular SOP review cycles and change control processesInterdepartmental Collaboration :
Partner with QA and Production on cleanroom control and contamination risk managementParticipate in cross-functional meetings, audits, and projectsProvide microbiological input for risk assessments and change controlsAudit and Regulatory Support :
Prepare and present microbiology data during internal and external auditsSupport regulatory inspections with required documentationMaintain an audit-ready state through continuous compliancePhysical Demands :
Ability 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 Qualifications :
Bachelors 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 :Familiarity 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 Suit and LIMS or quality documentation systemsBenefits
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 Employer
VPI 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.
