Quality Services Document Control Associate

Job Title: Quality Services Document Control Associate

Job Location: Westborough, MA 01581

Job Duration: 6 Months

Position Overview:

The Associate, Quality Assurance Documentation, will assist in maintaining and administering all aspects of the GMP document control system compliant with international cGMP expectations and client's policies and procedures.

Key Responsibilities:

• Document Issuance Support: Assist with the issuance of GxP documentation utilizing the Veeva Document Management System.
• Document Reconciliation Support: Assist with the reconciliation of returned GxP in the Veeva Document Management System and final disposition of reconciled documents.
• Document Control Support: Provide assistance with document control-related activities, including procedure creation and revision, as needed.
• Training Documentation Support: Provide assistance with creation of training folders and filing for associated training documentation in the Document Control room.
• Collaboration with Department Stakeholders: Assist with implementation of document change requests to ensure GxP documents are provided in a timely manner to stakeholders after creation or revision of a document.
• Documentation Discrepancy Resolution: Assist with investigating discrepancies related to missing or misplaced documentation.

Required Qualifications:

• BA/BS or equivalent with typically 1 years relevant experience or typically 0 years with Masters degree.
• Familiarity with most major elements of job description, direct experience with at least one major area.
• Basic familiarity with FDA regulations including Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations, FDA Guidance, and ICH Guidance.
• Proficiency with Microsoft Word formatting tools and techniques, to include manipulation of headers / footers, page control, document sections, orientation, styles, and editing markup / tracked changes.

Preferred Qualifications:

• Experience using document management software in a regulated industry.
• Proficiency in MS Excel, PowerPoint, and/or Visio to include creation / formatting of charts and data tables.