Microbiologist

MicrobiologistDepartment: Quality Control – MicrobiologyReports To: Director of Quality / QC ManagerFLSA Status: Exempt About Belleview Biosciences, LLCBelleview Biosciences is a trusted contract manufacturer specializing in over-the-counter (OTC) and prescription pharmaceuticals. As a DEA-licensed facility and prescription repackager, we uphold the highest regulatory and quality standards to provide safe, effective, and compliant pharmaceutical products. Our expertise extends across formulation, production, and packaging, ensuring efficient and reliable solutions for our clients. At Belleview Biosciences, we are dedicated to delivering high-quality products and supporting our partners with streamlined, cost-effective manufacturing services.Position SummaryThe Microbiologist is responsible for performing microbiological testing and environmental monitoring to ensure the quality, safety, and compliance of pharmaceutical products and manufacturing environments. This position supports Quality Control activities through routine microbiological analysis of raw materials, water systems, environmental samples, utilities, in-process materials, and finished products in accordance with FDA regulations, cGMP requirements, USP guidelines, and company procedures.The Microbiologist plays a critical role in maintaining the sterility assurance and contamination control program while supporting investigations, validations, and continuous improvement initiatives.Essential Duties and ResponsibilitiesPerform routine microbiological testing of:Raw materialsFinished productsIn-process materialsStability samplesWater systems (Purified Water and Water for Injection)Utilities including compressed gasesConduct Environmental Monitoring (EM) of classified manufacturing areas including:Viable air samplingNon-viable particle monitoringSurface monitoringPersonnel monitoringPerform microbial identification using approved laboratory methods.Conduct microbial enumeration and microbial limits testing.Perform sterility testing in accordance with USP <71>.Conduct bacterial endotoxin testing using LAL methods.Perform bioburden testing.Prepare microbiological media and reagents.Perform growth promotion testing of microbiological media.Maintain microbial culture collections and reference organisms.Review microbiological data and ensure compliance with established specifications.Document laboratory activities following Good Documentation Practices (GDP) and ALCOA+ data integrity principles.Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), environmental monitoring excursions, and laboratory deviations.Participate in contamination investigations and root cause analysis.Support cleaning validation and disinfectant efficacy studies.Assist with method validation, method verification, and method transfer activities.Calibrate, qualify, and maintain microbiology laboratory equipment.Support internal audits, customer audits, and FDA inspections.Ensure compliance with cGMP, USP, FDA, ICH, and company SOPs.Maintain laboratory cleanliness and inspection readiness.Participate in continuous improvement and quality initiatives.Perform other duties as assigned.QualificationsEducationBachelor's degree in Microbiology, Biology, Biochemistry, or related Life Sciences discipline required.Master's degree is preferred but not required.Experience2–5 years of microbiology laboratory experience in a pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment preferred.Experience working under FDA cGMP regulations.Experience supporting aseptic manufacturing environments is preferred.Experience with Environmental Monitoring programs is highly desirable.Required Knowledge, Skills & AbilitiesStrong understanding of microbiological laboratory techniquesKnowledge of FDA cGMP regulationsFamiliarity with USP microbiology chapters including:USP <61>USP <62>USP <71>USP <85>USP <1116>Knowledge of contamination control strategiesUnderstanding of aseptic processing principlesExperience with Environmental Monitoring programsStrong analytical and troubleshooting skillsExcellent documentation practicesAbility to investigate microbiological deviationsStrong organizational and time management skillsExcellent verbal and written communicationAbility to work independently and collaborativelyProficiency with Microsoft Office and Laboratory Information Management Systems (LIMS)Preferred Technical SkillsExperience with one or more of the following:Sterility TestingBioburden TestingBacterial Endotoxin Testing (LAL)Environmental MonitoringWater System MonitoringMicrobial IdentificationMedia PreparationGrowth Promotion TestingGram StainingMembrane FiltrationIncubator QualificationCleaning Validation SupportDisinfectant Efficacy StudiesAseptic TechniqueData Integrity (ALCOA+)Laboratory Investigations (OOS/OOT)Physical RequirementsAbility to stand for extended periods.Ability to lift up to 25 pounds.Ability to work within cleanroom and controlled environments.Ability to wear required Personal Protective Equipment (PPE), including sterile gowning.Manual dexterity to perform microbiological testing.Visual acuity for reading laboratory data and operating equipment.Work EnvironmentPharmaceutical manufacturing facilityMicrobiology Quality Control laboratoryCleanroom and aseptic manufacturing environmentsControlled environmental conditionsExposure to microbiological cultures, disinfectants, and laboratory chemicalsCompliance with all safety, biosafety, environmental, and cGMP requirementsKey Performance Indicators (KPIs)Environmental Monitoring compliance and trend performanceOn-time completion of microbiological testingRight-first-time laboratory resultsTimely closure of microbiological investigationsAccuracy and completeness of laboratory documentationLaboratory audit readinessData integrity complianceEquipment calibration and preventive maintenance complianceRegulatory inspection readinessCore CompetenciesAttention to DetailScientific and Analytical ThinkingRegulatory ComplianceProblem SolvingIntegrity and EthicsTeamworkCommunicationAccountabilityTime ManagementContinuous ImprovementQuality FocusEqual Opportunity EmployerWe are an Equal Opportunity Employer and are committed to creating an inclusive workplace where all employees are valued and respected. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under applicable law.