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Quality Documentation Specialist

Company: CritiTech Particle Engineering Solutions
Location: Lawrence
Posted on: May 23, 2023

Job Description:

The Quality Documentation Specialist (Specialist) is a member of the Quality Operations team and will report directly to the Director of Quality Operations. The Specialist serves as the point of control for the generation, maintenance, archival and retrieval of regulated documents for all cGMP and nonGMP activities. Responsibilities:

  • Maintain and archive all regulated documents
  • Manage and track the calibration and preventative maintenance programs
  • Log and track all environmental monitoring results
  • Issue and log controlled forms
  • Initiate, log, and track change control
  • Issue and revise SOPs
  • Issue and revise controlled forms
  • Maintain training data base
  • Issue and revise batch records
  • Issue and revise cleaning records
  • Assist with creating CoAs and CoCs
  • Assist with tracking and trending quality metrics
  • Create and revise specifications
  • Assign controlled documents numbers
  • Initiate and track Notification of Events (NOE) and Out of Specification (OOS) documents
  • Assist in the preparation of validation protocols and reports
  • Serve on SHE Committee and participate in safety walk-throughs, as needed
  • Coordinate training and/or assist in training technical staff as needed
  • Assist the Director of Quality, as needed
    Qualifications and Requirements: Required:
    • BS or BA and experience or combination of training and experience sufficient to discharge the duties of the position.
    • Previous experience in working with people in a multi-disciplinary team environment.
    • Computer skills sufficient to discharge the duties of the position including but not limited to word processing, spreadsheets, presentation (Microsoft Word, Excel, PowerPoint,), and various database programs.
    • Teamwork - the ability to work well with and assist personnel in a highly cross-functional team environment.
    • Communication Skills - ability to expresses oneself clearly, concisely, and effectively to associates, customers, suppliers, and partners over the phone; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate for the audience.
    • Respect for Others - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
    • Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables. Preferred:
      • Previous experience in the documentation, operation, maintenance, calibration, and validation of laboratory equipment in a regulated laboratory environment.
      • Previous experience with FDA, cGMP and GLP regulations as they relate to a controlled laboratory and manufacturing environment.
      • Previous direct experience with interactions with regulatory agencies.
      • Advanced usage of Microsoft Word.
      • Proficiency with technical editing and use of style guides (ACS).
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Keywords: CritiTech Particle Engineering Solutions, Lawrence , Quality Documentation Specialist, Other , Lawrence, Kansas

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