Overview

The Document Specialist is responsible to assist in the flow of controlled documents and training.

Candidate Requirements

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.

Responsibilities

  • 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

Skills

  • 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.

Education

  • 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.