Responsibilities:

• Excellent employment opportunity for a QC Associate III in the Fremont, CA area.
• Performs sampling/testing/inspection of raw materials, conducts lab investigations, and reports aberrant results to management.
• Includes, not limited to: Pulling and aliquoting raw material samples and distributing to the appropriate laboratories.
• Prepares paperwork, ships samples, and follows-up with appropriate testing laboratories.
• AQL inspection (e.g., visual, dimension, etc.)
• On call/weekend/swing shift coverage for urgent samples.
• Data entry and reviews QC documentation (e.g., test results, data packets, etc.)
• Generates, reviews and/or maintains records or documents in a detailed and consistent manner (e.g., sample summary form, test records, etc.).
• Reconciles samples.
• Perform required reviews of appropriate forms (e.g., test records) and logbooks.
• Performs an Owner role for Change Controls and Deviations
• Prepares and reviews-trend reports, generate metrics and other reports as needed.
• Maintains raw material data. Revises SOPs, training doc, etc.
• Ensures equipment calibration and preventive maintenance are up to date.
• Performs an Owner role for Change Controls and Deviations.

Experience:

• Bachelors' Degree in a Scientific Discipline. In depth experience in a laboratory environment Five (5) years cGMP or appropriate experience required.
• Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859 or other sampling standards desired.
• Strong technical writing required.
• Knowledge of CFR, USP, and ICH required.
• Knowledge of SAP Track wise and LIMS desired.
• Working knowledge of Microsoft Office systems, LIMS, lab instrumentation and other relevant systems.
• Demonstrated problem-detection and problem-resolution skills required
• Lifting, carrying, pushing or pulling up to 50 pounds occasionally Frequent periods of sitting, walking, and standing
• Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat
• Occasional low-level work, fine finger dexterity/ including grasping or pinching required
• Occasional use of personal protective equipment
• Required Skills: GMP, USP, EUROPEAN PHARMACOPIA, MS OFFICE, LIMS,
• Additional Skills: GMP ISO, ICH,