Quality Control Specialist
3 days ago
Fladger Assoc. Inc. is seeking a highly skilled QC Associate III to join our team in Fremont, CA.
Job Summary:We are looking for a detail-oriented and organized individual to perform sampling, testing, and inspection of raw materials, conduct lab investigations, and report aberrant results to management.
Responsibilities:- Conduct sampling and testing of raw materials to ensure quality and compliance with regulatory requirements.
- Perform laboratory investigations and report findings to management.
- Prepare and distribute samples to testing laboratories, and follow up on test results.
- Conduct AQL inspections and maintain accurate records.
- Provide on-call/weekend/swing shift coverage for urgent samples.
- Enter and review data, and maintain accurate records of QC documentation.
- Generate and review reports, and maintain records of sample summaries, test records, and other relevant documents.
- Reconcile samples and perform required reviews of forms and logbooks.
- Perform an Owner role for Change Controls and Deviations.
- Prepare and review trend reports, generate metrics, and other reports as needed.
- Maintain raw material data and revise SOPs, training documents, and other relevant materials.
- Ensure equipment calibration and preventive maintenance are up to date.
- Bachelor's Degree in a Scientific Discipline.
- Five (5) years of cGMP or appropriate experience required.
- Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859, or other sampling standards desired.
- Strong technical writing skills 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.
- 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.
- GMP, USP, EUROPEAN PHARMACOPIA, MS OFFICE, LIMS.
- Additional Skills: GMP ISO, ICH.
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