Quality System Document Control Administrator

Job Title: Quality System Document Control Administrator
Location: Ward Hill, MA
Duration: 6+ months (Possibility of Extension)
Shift: 1st shift (Monday – Friday)
Pay rate: $35/Hr on W2

Job Description:
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.
How will you get here?


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.
• Initiate the periodic review process for controlled documents by their due dates and associated metrics.
• Ensure adherence to established templates and procedures.
• 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.
• Store, manage, and track documents throughout entire lifecycle.
• Scan, image, organize, and maintain documents.
• Archive inactive records in accordance with the records retention schedule.
• Assist with audit preparation and audit support as required.
• Maintain curricula, learning plans, and training records, record training and learning events via the internal Training Management System.
• Update internal Training Management System as needed to support internal Fisher training requirements.
• Run reports in the Training Management System and provide training data to functional areas for trending purposes as requested.
• Manage creation and distribution of log books.
• Troubleshoot issues found in the Training Management System and enter courses/tests e-learning content.
• Support other business needs as required.
• 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).
• Ability to understand and implement priorities and workload and to establish strong collaborative relationships with peers.
• Good communication, diplomacy skills and be able to work effectively with internal stakeholders.
• Must be detailed oriented to detect errors or deficiencies when reviewing and releasing documents for approval.
• Ability to work effectively within various electronic document templates and provide assistance and guidance to authors when requested in relation to these documents.
• Experience with electronic Document Management Systems.
• Experience with electronic Training Management Systems

Physical Requirements
• This position requires standing, bending, reaching, walking and talking as well as exerting up to 20 pounds.