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Quality Control Technician

San Diego Metro Area, CA

Posted: 01/25/2018 Job Type: Engineering Job Number: JN -012018-20800
Education / Experience:
  • Must have experience in a regulated environment, GMP documentation, NCMRs.
  • NGS is a plus but it isn t a must have if they don t have it either.
  • A background in QC is ideal but manufacturing background could work as well.
  • Candidates with an R&D background will not be considered
  • Requires knowledge and skills normally acquired through the successful completion of a BS Degree in a scientific discipline.
  • 5+ years of experience in a GMP regulated industry or equivalent combination of education and experience.
Job Responsibilities:
  • Educates department staff.
  • Successfully generates, implements, preserves and enriches department Standard Operating Procedures (SOPs), acceptance criteria, etc., for products tested.
  • Effectively and economically proofs raw materials, in process and final product and generates testing data.
  • Releases products to Quality Assurance for final approval.
  • Ensures that all customer complaints and inquiries are resolved.
  • Conducts and maintains the real time stability study testing.
  • Maintains inventory materials used in quality control.
  • Evaluates price, quality and availability of raw materials used by the department.
  • Cooperates and communicates with external and internal customers.
Skills / Abilities:
  • Working knowledge of medical device quality and regulatory requirements including QSR and ISO quality system standards and the IVD Directive.
  • Working knowledge of a production environment, including use of SOPs, batch records, ERP systems and purchasing specifications.
  • Ability to follow Standard Operating Procedures (SOPs).
  • Proficient in Microsoft Office Suite (Outlook, Word, Excel and Powerpoint).
  • Working knowledge of the use of Adobe Acrobat, Illustrator, and Photoshop.
  • Attention to detail.
  • Ability to work independently as well as in a team environment.
  • Excellent communication skills with the ability to train employees.
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