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Quality Control Analyst

Fremont, CaliforniaPEAK Technical Staffing USA


Our client is looking for a Quality Control Analyst who will be performing QC assays, INC inspection of reagents and components, writing and establishing specifications, assisting in the validation of QC assays, Stability Studies, assisting production with batch record reviews and writing standard operating procedures.  

Essential Duties and Responsibilities:

  • Conduct routine and non-routine analyses of in-process materials, raw materials, finished goods, and/or stability samples using established procedures.
  • Perform routine incoming inspection of raw materials and components used in manufacturing.
  • Complete appropriate testing and release documentation for batch records.  Review data to ensure accuracy and regulatory compliance.
  • Develop and coordinate special activities and programs necessary to meet and maintain quality standards and reliability of manufactured products.
  • Works with other production personnel to coordinate test requirements and priorities.
  • Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
  • Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
  • Develop, write and/or revise standard quality control and incoming inspection operating procedures as needed.
  • Write technical reports or documentation such as deviation reports, testing results, and trend analyses.
  • Coordinate testing with contract laboratories and vendors as needed.
  • Investigate or report questionable test results. 
  • Participate in out-of-specification and failure investigations and recommend corrective actions.
  • Ensuring product compliance with international and national regulations and quality standards. 
  • Ensure that lab cleanliness and safety standards are maintained.
  • In depth knowledge of statistical methods for the analysis of experimental data desirable.

Qualifications:

  • Bachelor’s Degree or Master’s Degree in biological science or similar scientific discipline.
  • 3+ years of experience in Quality Control within medical device and in-vitro diagnostics, or relevant industry.
  • Strong laboratory, analytical and documentation skills, with attention to detail and demonstrated knowledge of GMP/cGLP principles.
  • Understand basic chemical and biological safety hazards in a standard laboratory setting.
  • Solid technical knowledge of instrumentation techniques and principles for the analysis of chemical/bio reagents. 
  • Prior experience with automated reagent analyzers such as coagulation devices a plus.
  • Knowledge in the use of basic measurement tools such as calipers, balances, meters, as well as use of measuring pipettes.
  • Knowledge of the application of statistical techniques and tools.
  • Ability to work in a dynamic team environment, creative thinker, and problem solver.
  • Strong oral and written communication skills.
  • Strong time management skills that adapt to meeting business needs, schedules and priorities.
  • Ability to work independently and under minimal supervision or guidance.