Sr. Quality Compliance Specialit - CA | Thousand Oaks,California (Onsite)

Dice is the leading career destination for tech experts at every stage of their careers. Our client, Stellent IT LLC, is seeking the following. Apply via Dice today!Hi,Position: Sr. Quality Compliance SpecialistLocation: Thousand Oaks, California (Onsite)Duration: 12 + MonthsInterview Mode: VideoVISA : , OPTGCJDMUST HAVE: LAB & GMP ExperienceDrive analytical method validation/ transfer of laboratory methodologies Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation. Strong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements.Essential Duties and Responsibilities:Drive analytical method validation/ transfer of laboratory methodologiesSupport the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocolsSupport troubleshooting of analytical methodsEnsure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.Responsible for protocol and report generation and other technical documents as required. This may include supporting raw material qualification for new productsUse sound scientific principles and statistical techniques to solve problems and make recommendations.May Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.Responsible for deliverables to ensure timelines and milestones are met.Other duties as assigned.QualificationsStrong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirementsKnowledge of analytical methods and operations with strong emphasis in problem-solving.Knowledge about analytical method validation.Intermediate statistical knowledge and experience with data analysisKnowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.Basic knowledge about regulatory requirements concerning analytical instrumentation, and test methodsSubstantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.Ability to complete tasks with minimal direction, demonstration of basic project management skills.Ability to multi task in a highly dynamic and diverse environment.Attention to detail, good organization, and time management skills to meet deadlines.Proficient in Microsoft Office.Strategically and business-oriented thinkingEducation and/or experienceBachelor's Degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.Minimum of 1 year of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.Physical DemandThe overall physical exertion of this position requires light to medium work.Working EnvironmentNormal office and laboratory environment.May need to work in controlled or clean room environments requiring special gowning.May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.Able to work more than 8 hours a day or 40 hours a work week as needed.Additional Notes:Nice to have the KNEAT Program, not required Experienced in reviewing and approving Life Cycle Validation Documents including:Familiar with paperless validation software for life sciencesCommissioning, Installation, Operational and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacture plant.Computer System Validation protocols and reports, including SCADA, MES.QC/Micro Laboratory Instrument Qualification and method validation.Niranjan Kumar | Technical RecruiterEmail: Stellent IT | office :