Quality System Document Control Administrator

Job Description

Job Title: Quality System Document Control Administrator

Location: Ward Hill, MA 01835 - Onsite

Duration: 6 months

Shift hours: M-F 8-5 (may leave earlier if site is closed)

Pay rate: $35.00/hour on W2

Summary:

• The Quality System Document Control (QSDC) Administrator is responsible for handling all Quality System controlled documents (Standard Operating Procedures (SOPs), Work Instructions (WIs), Forms, Policies, Knowledge Assessments (KAs), among others).
• The QSDC Administrator will circulate and track the documents through the review, approval and distribution process.
• The QSDC Administrator will upload and link the documents into the Document and Training System.

Education:

• Associates Degree.

Responsibilities:

• Maintain all controlled documents and assist company personnel with the creation and revision of all controlled documentation (i.e. SOPs, WIs, Forms, KAs, etc.).
• Monitor shared mailbox and respond to company personnel for documents that require to be created, revised and/or inactivated.
• Verify document change requests, perform review of documents for accuracy and consistency before circulating for approval.
• Assist document authors with navigation in electronic document management system, formatting, and workflows of documents.
• Assist with audit preparation and audit support as required.
• Run reports in the Training Management System and provide training data to functional areas for trending purposes as requested.
• Troubleshoot issues found in the Training Management System and enter courses/tests e-learning content.
• Present training on EDMS system to site employees
• Regularly attend meetings regarding training and document systems

Knowledge, Skills, Abilities:

• A minimum of 3 years’ experience in the pharmaceutical or related regulated industry.
• Familiar with Quality Systems (change control, deviations, documentation management, and training system).
• Experience with electronic Document Management Systems.
• Experience with electronic Training Management Systems