Temporary Document Control Specialist I

Purpose and Scope

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

Essential Duties & 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.

Knowledge, Skills & Abilities

• Experience with Microsoft Word, Excel, and Access.
• Knowledgeable in FDA Good manufacturing Practices (cGMP) preferred.
• 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.
• Veeva experience preferred.

Education & Experience

• High school diploma or GED required.
• Some college level coursework preferred.
• Two or more years of experience in an administrative position required.

Working Conditions

• Working conditions are normal for an office environment.
• Work may require occasional overtime.