Temporary Document Control Specialist I

TolmarWindsor, CO
5d$23

About The Position

The Document Control Specialist I supports Tolmar by performing functions involving the processing of controlled documents and maintenance of the Document Control system.

Requirements

  • Experience with Microsoft Word, Excel, and Access.
  • Excellent organizational skills.
  • Ability to maintain focus on detail-oriented, repetitive tasks.
  • Effective verbal and written communication abilities to support broad range of internal and external customers.
  • Ability to interact with management, peers, and members of other departments in team settings in a respectful and professional manner.
  • High school diploma or GED required.
  • Two or more years of experience in an administrative position required.

Nice To Haves

  • Knowledgeable in FDA Good manufacturing Practices (cGMP) preferred.
  • Veeva experience preferred.
  • Some college level coursework preferred.

Responsibilities

  • Issue batch records and associated documents including copy verification.
  • Navigate in the Tolmar Network drives for storage of electronic documents, as applicable.
  • Update and maintain associated databases and tracking systems including, batch record issuance, lab notebook issuance and archival and validation document numbers.
  • Ensure employee signature cards are scanned, filed and stored in secured location for review by departments to verify signature.
  • Maintain electronic and paper copy files, as needed per the retention schedule.
  • Coordinate and prioritize scanning of files and other documents/records ensuring proper retention requirements including Department document submissions, laboratory notebooks, batch records, logbooks and QA receiving paperwork.
  • Perform the daily Document Distribution activities. Maintain document/file room processes, including filing of documents.
  • Process all electronic document system types ensuring company-wide adherence to procedures. Complete Electronic Document Management System formatting reviews for documents. Aid all levels of personnel/management regarding the creation and revision of documents within the document management system.
  • Assist with revision of department assigned documents.
  • Maintain and submit supply requests for the document control department.
  • Complete limited immediate actions, corrective actions or change control change actions within Electronic Quality Management System that apply to associated duties.
  • Participate in recurring cross-functional meetings with departments that share KPI/processes as needed.
  • Escalate and ensure open communication when discrepancies are found in any work.
  • Perform other duties as assigned.
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