||Document Control Specialist
The Document Control Specialist is responsible for the collecting, maintaining, and distributing all documents necessary to support Quality Management System, drug development and Regulatory filings. This person will format, file, archive, and maintain all of the documentation generated or required across various products and the company, including Standard Operating Procedures (SOPs), Forms, Validation documentation, and Regulatory submission and source files.
- Perform day-to-day Document Control activities: Process DCR packages and review for correctness and completeness; monitor and update in-process documents; create, assign and archive QA controlled source documents and reports; assist in managing the electronic document repository; and create reports.
- Perform document-level publishing activities: Ensure Word documents will convert to submission-ready PDFs; update word heading styles to produce PDF bookmarks; ensure internal cross-references are generated properly; edit documents to meet internal submission standards
- Performs duties in support of established records management procedures, including scanning, filing and managing offsite records storage and retrieval.
- Participate in internal and external audits
- Assist in updating SOPs
- Participate in regulatory inspections
- Provide user assistance with using the document repository
- Provide user assistance and training on the use of Word and proper templates
Education and Training: (degree, certifications, etc.)
- Bachelors degree with 2 years of general document control experience
- 2-5 years of pharmaceutical experience in a GMP environment.
- Minimum of 2 years experience using and administering electronic document management tools
- General knowledge of electronic documentation systems, data retrieval, and electronic file formats
- Working knowledge of Quality Systems, GMP-related requirements and ICH guidelines, desirable
- Willing to learn new areas of responsibility
- Ability to work independently and cross-functionally
- Ability to work effectively in a team environment
- Ability to analyze and reconcile moderately complex issues
- Must have demonstrated initiative and accountability in a fast paced environment
- Excellent verbal and written communication and interpersonal skills
- Proficient with computers and word processing software (i.e. Microsoft Office products)
- Excellent Microsoft Word skills, including the use of heading styles, captions and cross-references, bookmarks, etc.
- Experience with a Word template suite preferred