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Quality Specialist II-Customer Audits

Company: Thermo Fisher Scientific
Location: Logan
Posted on: February 3, 2020

Job Description:

Position Summary: Assist and support BioProduction in meeting Quality objectives and assure compliance with industry standards. Determine, organize and apply necessary resources to meet identified Quality Requirements. Ensure Corporate, Regulatory, Quality requirements are met. Ensure that customer expectations are met or exceeded.Key Responsibilities:

  • Review all lot records prior to release
  • Release Manufacturing Lots
  • Participate & Maintain Investigative Processes (PNs, NCMs, Deviations, CAPA)
  • Participate in self-inspection activities as assigned
  • Generate COA Templates
  • Review and approve documents (SOPs, WIDs, PCDs, FCDs)
  • Review and approve specifications (SPECS)
  • Host/Support customer audits as assigned
  • Other QA tasks/responsibilities as assignedMinimum Requirements/Qualifications:
    • Associate Degree
    • Ability to work independently with little direct supervision
    • General knowledge of computer systems
    • Experience working in cGMP environment
    • General knowledge of ISO 13485
    • Organization Skills
    • Attention to detail
    • Problem solving skills
    • Great interpersonal skillsNon-Negotiable Hiring Criteria:
      • Associate Degree or equivalent work experience in Quality field (2+ years)
      • General knowledge of computer systems
      • Experience working in cGMP environment (5+ years)

Keywords: Thermo Fisher Scientific, Logan , Quality Specialist II-Customer Audits, Accounting, Auditing , Logan, Utah

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