Document Control Specialist I

Tolmar Careers • Windsor, CO

14h • Onsite

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. This role is responsible for issuing batch records and associated documents, maintaining databases and tracking systems, coordinating scanning of files, processing electronic document system types, and assisting with document revisions. The specialist will also handle daily document distribution, maintain document/file room processes, and complete limited actions within the Electronic Quality Management System. Collaboration with other departments and clear communication of discrepancies are essential.

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.

Benefits

• Market-based base pay
• Strong benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED