Quality Control Scientist
Katalyst CRO
Responsibilities Drive analytical method validation/ transfer of laboratory methodologies. Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols. Support troubleshooting of analytical methods. Ensure 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 products. Use 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. Requirements Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent. Minimum of 7 years of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree. 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 science. Commissioning, 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. Skills Strong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements. Knowledge of analytical methods and operations with strong emphasis in problem-solving. Knowledge about analytical method validation. Intermediate statistical knowledge and experience with data analysis. Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation. Basic knowledge about regulatory requirements concerning analytical instrumentation, and test methods. Substantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc. Proficient in Microsoft Office. Strategically and business-oriented thinking. #J-18808-Ljbffr
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