Records Management Specialist

Document Control | Santa Ana, CA

Job Description:

We are seeking a Records Management Specialist.  This individual will be responsible for protection, retention, retrieval, and destruction of company records in compliance with SOPs, ISO 13485, & GMP standards.  Works with IT and EDMS system administrators to ensure electronic records are maintained for the correct period in a retrievable format and appropriately indexed for searchability.

Responsibilities:

  • Scanning, uploading, organizing, and maintaining records according to a predetermined retention schedule
  • Review records prepared for transfer to off-site storage meet all requirements and coordinate records transfer. Ensure records are being transferred in a timely manner
  • Fulfill retrieval requests from on & off-site storage. Perform periodic checks to verify retrievability of company’s IP
  • Coordinate retention, transfer, or destruction of customer and company records
  • Issue logbooks and laboratory notebooks. Perform periodic checks to verify retrievability of company’s IP

Experience/Education:

  • A minimum of two (2) years’ related experience
  • Working knowledge of current industry regulations, e.g., cGMP, 21 CFR 820, ISO 13485, EU Medical Device Regulation 2017/745, TGA, & Canadian Medical Device Regulations, and quality management systems
  • Working knowledge of problem-solving tools and root cause analysis
  • Working knowledge of records management systems

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Principals only. No recruiters please.

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

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