QC Associate - Raw Materials

Fremont, CA Contract Duration: 12- 36 months Rate: Negotiable Salary: NA, $1.00 Responsibilities: Excellent employment opportunity for a QC Associate - Raw Materials in the Fremont, CA area. Perform sampling/testing/inspection of raw materials, conducts lab investigations, problem-solves, and reports aberrant results to management. Pulling and aliquoting raw material samples and distributing to the appropriate laboratories AQL inspection (e.g., visual defects, dimension testing, and all required attributes Ship samples to appropriate testing laboratories and prepares paperwork for testing. On call coverage for urgent samples. Ensure sample integrity is intact, paperwork to be completed, correct and LIMS entries are performed. Reviews QC test results Generate, review and/or maintain records or documents in a detailed and consistent manner (e.g., sample summary form, test records, retain sample forms, etc.). Prepare sample reconciliation reports and other reports as needed. Assist with QC's data management, including data review and trending. Perform logbook and/or LIMS entries when using equipment/instruments. Reconciles samples. Perform weekly and monthly reviews of appropriate forms (e.g., test records) and logbooks. Perform an Owner role for Change Controls and Deviations Independently writes and/or updates raw material specifications and reports. Ensure all raw material documentation and reports are reviewed and are in accordance with the raw material specifications. Experience: Bachelors' Degree in a Scientific Discipline. In depth experience in a laboratory environment with direct experience in bio-analytical techniques and equipment related to the testing of biotechnological products or chemicals Six (6) years cGMP or appropriate experience required. Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859 or other sampling standards required. Strong technical writing required Knowledge of CFR, USP, and ICH required. Knowledge of SAP, Trackwise and LIMS desired. Working knowledge of Microsoft Office systems, LIMS, lab instrumentation and other relevant systems Highly productive, attention to detail, ability to manage time and prioritize tasks with input from manager to meet time lines. Lifting, carrying, pushing or pulling up to 50 pounds occasionally Fladger Associates