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Quality Assurance Specialist

Company: Cypress HCM
Location: Carlsbad
Posted on: February 24, 2021

Job Description:

Responsibilities:

  • Maintenance of the QS sub-systems. Ensure log and report completeness, and ensure that the reports are scanned with evidence.
  • Review and/or write of CA, PA, NCMRs, Complaints, and Deviation reports.
  • Document control program. Manage the S drive folder and the hard copy files and ensure traceability of the approved documents can be performed at any time.
  • Assist with client audits and follow-up action items.
  • Complete vendor approval questionnaires.
  • Maintenance of lab notebooks, batch records, equipment files.
  • Schedule, organize, perform and write internal audits.
  • Reporting of QMS status for projects, this includes but not limited to, preventative actions, corrective actions, NCMR, complaints, and deviations.
  • Keep up to date with archiving of files.
  • Review and release originated or resale product
  • Tasks will expand once the above areas are managed well.
    Requirements:
    • Knowledgeable of and has worked with ISO 9001 and ISO 13485.
    • Knowledgeable of Risk Management.
    • Moderate to extensive experience in cGMP and manufacturing environment.
    • Internal auditing experience preferred.
    • Confident in decision making skills.
      Education:
      • At Least 2 years of experience
      • College is a plus Additional Skills:
        • Moderate to extensive skills in WORD, EXCEL, and PPT
        • Ability to prioritize tasks and to be flexible with handling last minute urgent matters

Keywords: Cypress HCM, San Diego , Quality Assurance Specialist, Other , Carlsbad, California

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