{"schemaVersion":"jobsearcher.job.v1","id":"60028bb94dfe039bfd16ab7e","url":"https://jobsearcher.com/jobs/60028bb94dfe039bfd16ab7e","canonicalUrl":"https://jobsearcher.com/jobs/60028bb94dfe039bfd16ab7e","title":"Quality Control Validation Scientist","description":"Job Description:\nAs a QC Analytical Scientist, you will support various Quality Control activities within the AQC department. Key responsibilities are to transfer and execute analytical methods, including raw materials, for use in a cGMP environment in Quality control, both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).\n\nResponsibilities\n\nDrive analytical method validation/ transfer of laboratory methodologies.\n\nSupport the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols.\n\nSupport troubleshooting of analytical methods.\n\nEnsure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.\n\nResponsible for protocol and report generation and other technical documents as required. This may include supporting raw material qualification for new products.\n\nUse sound scientific principles and statistical techniques to solve problems and make recommendations.\n\nMay support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.\n\nResponsible for deliverables to ensure timelines and milestones are met.\n\nRequirements\n\nBachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.\n\nMinimum of 1 year of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.\n\nStrong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements.\n\nKnowledge of analytical methods and operations with strong emphasis in problem-solving.\n\nKnowledge about analytical method validation.\n\nIntermediate statistical knowledge and experience with data analysis.\n\nKnowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.\n\nBasic knowledge about regulatory requirements concerning analytical instrumentation, and test methods.\n\nSubstantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.\n\nAbility to complete tasks with minimal direction, demonstration of basic project management skills.\n\nAbility to multi‑task in a highly dynamic and diverse environment.\n\nAttention to detail, good organization, and time management skills to meet deadlines.\n\nProficient in Microsoft Office.\n\nStrategically and business‑oriented thinking.\n\nPhysical Demand\n\nThe overall physical exertion of this position requires light to medium work.\n\nWorking Environment.\n\nNormal office and laboratory environment.\n\nMay need to work in controlled or clean room environments requiring special gowning.\n\nMay work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.\n\nAble to work more than 8 hours a day or 40 hours a work week as needed.\n\nAdditional Notes\n\nNice to have the KNEAT Program, not required.\n\nExperienced in reviewing and approving Life Cycle Validation Documents including:\n\nFamiliar with paperless validation software for life sciences.\n\nCommissioning, Installation, Operational and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacture plant.\n\nComputer System Validation protocols and reports, including SCADA, MES.\n\nQC/Micro Laboratory Instrument Qualification and method validation.\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Thousand Oaks","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-07-02T03:39:43.291Z","occupations":[{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Control Validation Scientist","description":"Job Description:\nAs a QC Analytical Scientist, you will support various Quality Control activities within the AQC department. Key responsibilities are to transfer and execute analytical methods, including raw materials, for use in a cGMP environment in Quality control, both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).\n\nResponsibilities\n\nDrive analytical method validation/ transfer of laboratory methodologies.\n\nSupport the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols.\n\nSupport troubleshooting of analytical methods.\n\nEnsure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.\n\nResponsible for protocol and report generation and other technical documents as required. This may include supporting raw material qualification for new products.\n\nUse sound scientific principles and statistical techniques to solve problems and make recommendations.\n\nMay support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.\n\nResponsible for deliverables to ensure timelines and milestones are met.\n\nRequirements\n\nBachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.\n\nMinimum of 1 year of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.\n\nStrong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements.\n\nKnowledge of analytical methods and operations with strong emphasis in problem-solving.\n\nKnowledge about analytical method validation.\n\nIntermediate statistical knowledge and experience with data analysis.\n\nKnowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.\n\nBasic knowledge about regulatory requirements concerning analytical instrumentation, and test methods.\n\nSubstantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.\n\nAbility to complete tasks with minimal direction, demonstration of basic project management skills.\n\nAbility to multi‑task in a highly dynamic and diverse environment.\n\nAttention to detail, good organization, and time management skills to meet deadlines.\n\nProficient in Microsoft Office.\n\nStrategically and business‑oriented thinking.\n\nPhysical Demand\n\nThe overall physical exertion of this position requires light to medium work.\n\nWorking Environment.\n\nNormal office and laboratory environment.\n\nMay need to work in controlled or clean room environments requiring special gowning.\n\nMay work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.\n\nAble to work more than 8 hours a day or 40 hours a work week as needed.\n\nAdditional Notes\n\nNice to have the KNEAT Program, not required.\n\nExperienced in reviewing and approving Life Cycle Validation Documents including:\n\nFamiliar with paperless validation software for life sciences.\n\nCommissioning, Installation, Operational and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacture plant.\n\nComputer System Validation protocols and reports, including SCADA, MES.\n\nQC/Micro Laboratory Instrument Qualification and method validation.\n\n#J-18808-Ljbffr","datePosted":"2026-07-02T03:39:43.291Z","dateModified":"2026-07-02T03:39:43.291Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Thousand Oaks","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"60028bb94dfe039bfd16ab7e"},"url":"https://jobsearcher.com/jobs/60028bb94dfe039bfd16ab7e"}}