Quality Control Validation Scientist

Contract – Potential to last up to 6 Months, to start Thousand Oaks, CA PR: $30-43/hour Job Summary As 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). Job 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. Responsible for deliverables to ensure timelines and milestones are met. Other duties as assigned. Education & Qualifications Required: Bachelor’s Degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or equivalent. Minimum of 1 year of analytical development or validation experience in a pharmaceutical or biopharmaceutical manufacturing environment. Experience reviewing and approving Life Cycle Validation Documents using paperless validation software. Proven experience with Commissioning, Installation, Operational, and Performance Qualification (IOQ/PQ) protocols and reports for equipment, facilities, utilities, and computer systems (including SCADA and MES). Background in QC/Micro laboratory instrument qualification and analytical method validation. Intermediate statistical knowledge and data analysis capabilities. Substantial understanding of regulatory standards (cGMP, QSR, USP, 21CFR, ICH, etc.). Preferred: Experience with the KNEAT Program. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). #J-18808-Ljbffr Randstad USA