The Document Specialist is responsible to assist in the flow of controlled documents and training.
QA/QC professional with a minimum of 1-5 years experience within a pharma, biopharma and/or biotech manufacturing environment (including aseptic filling environment). Must have strong interpersonal skills and be a team player. The person also must be able to communicate professionally with clients and regulatory agencies. DEA experience is a plus.
- Assess for accuracy and process Document Change Request workflows.
- Demonstrate expertise in Microsoft Word and other Microsoft Office applications to meet established document formatting requirements.
- Edit, route and coordinate approval and implementation of documents in the MasterControl Document Management System (DMS)
- Coordinate document review and approval, along with Project Management
- Use and maintain the Document Management System according to standard operating proceduresIssue, maintain, and reconcile controlled documents, including logbooks, controlled copies, execution copies, controlled forms.
- Provide necessary office and administrative support
- Coordinate archival (and retrieval, electronic searching, etc.) of GMP documents with offsite records management vendor, boxing, organizing and shipping records at regular intervals.
- Support internal, client, and external regulatory inspections by providing documents from the MasterControl DMS, including offsite searching, electronic and physical retrieval from vendor
- MS Word, MS Excel. Editing for grammar and conformance to templates and procedure requirements.
- Excellent communication (verbal and written, including grammar) and interpersonal skills.
- Self starter; ability to think critically to solve problems independently.
- Ability to shift between various projects and work in a fast paced environment with various internal and external customers.
- Strong attention to detail.
- Experience with document management; previous GMP environment experience preferred.
- Experience writing/editing/proofreading SOPs, Work Instructions, Policies, Forms, Logs.
- Fluent in Microsoft Word formatting and tools.
- Above average familiarity with MS Excel, including typical creation and use of spreadsheets, reports, etc.
- Previous experience with MasterControl desirable.
- BS or BA in Life Sciences or applicable relevant experience
If you would like to be considered, please submit your resume on our careers page.