Unknown Company

Microbiologist III

camarillo, ca • Posted 4 days ago
Onsite Full Time General
Quality Control Microbiologist III – Camarillo, CAThe Quality Control Microbiologist III performs quality activities in support of product production and releases. The QC Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results.To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.We proudly offer:Generous benefit options (eligible first day of employment)Paid training, vacation and holidays (vacation accrual begins on first day of employment)Career advancement opportunitiesEducation reimbursement401K program with matching contributionsLearning platformAnd more!Responsibilities:Lead and/or support quality event investigations for out-of-specification (OOS), out-of-trend (OOT) or nonconformance eventsPerform environmental monitoring of clean rooms (under ISO and EU specifications)Perform and review QC testing (Endotoxin, Bioburden, TOC, Conductivity, Growth Promotion Assay, etc.) for manufacturing, raw materials, in-process materials, intermediates and final productDemonstrate technical proficiency in test procedures and ensure QC activities are carried out using applicable regulatory requirements (FDA, USP, ICH etc.)Participate in audits, client investigations, and project-related activitiesLead and/or support activities associated with Change Control, CAPAs, client audit response, work orders, etc.Receive and process samples to meet production/client timelinesRead, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing resultsPrepare and send out samples for microbiological identificationEnsure QC sample testing (e.g. in-process, lot release, stability, EM, water) and data approval deadlines are metWork closely and collaborate in a team environment with QC Analytical and Quality Assurance, Manufacturing, Technical Services, Materials Receiving, and Research and DevelopmentEnsure the successful implementation and execution of new QC methods/procedures and equipmentPerform trending of QC data and present information to ManagementPerform general laboratory housekeepingAuthor, review, and approve microbiology test results and analytical methods as neededEnsure QC sample testing (e.g. in-process, lot release, stability, EM, water) and data approval deadlines are metSupport Manufacturing with client-specific testing requirementsInspection of media fillsQualifications:Bachelor's Degree in Microbiology or related fieldMinimum 5+ years' industry experience in a GMP sterile finish or pharmaceutical cleanroom environmentWilling to work flexible hours (nights and weekends), as-neededKnowledge, skills and abilities:Proficient in the validation/qualification of lab microbiological techniques preferredKnowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plusKnowledgeable in USP <61>, <62>, <71>, and <85>Attention to details and following GMP methods and instructionsOther Qualifications:Must pass a background checkMust pass a drug screenMay be required to pass Occupational Health ScreeningMay be required to obtain and maintain gowning certificationMay be required to obtain and maintain media qualificationPay Range: $84,000-$105,600/yearEducation, experience, location and tenure may be considered along with internal equity when job offers are extended.All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
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