Quality System Document Control Administrator (Pharmaceutical)

Category:

Life Science

Employment Type:

Direct Hire

Reference:

BH-385079

Yoh is hiring for a Quality System Document Control Administrator
for our Pharmaceutical manufacturing client here in St. Louis, Missouri.
The Quality System Document Control Administrator is responsible for handling all Quality System controlled documents, Standard Operating Procedures (SOPs), Work Instructions (WIs), Forms, Policies, Knowledge Assessments (KAs), etc.. This individual will circulate and track the documents through the review, approval, and distribution process.

Hours:
M-F; 6am-2:30pm

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.
• 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 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 logbooks.
• 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

• 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