Quality Control Specialist

4 weeks ago


Fremont, California, United States Fladger Assoc. Inc. Full time
Job Title: QC Associate III

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.
Requirements:
  • 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.
Preferred Skills:
  • GMP, USP, EUROPEAN PHARMACOPIA, MS OFFICE, LIMS.
  • Additional Skills: GMP ISO, ICH.


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