GMP Quality Documentation Coordinator
The Quality Document contractor is an individual contributor who is responsible for supporting day to day activities within the Document Management department. Responsible for compliance in accordance with Document Management procedures and will assist with ongoing Quality documentation deliverables driven by business objectives and assigned by management.
Build Training requirements for employee. Electronic Documentation Management System experience preferred.
Assist with daily data entry in training system.
Assist with scanning activities.
Assist with year-end record retention/archival activities.
Working hours: 8:00 AM - 5:00 PM
--Coordinates, proofreads, formats, controlled documents supporting the manufacturing and testing of products.
--Data entry and daily maintenance of the QMS training system CATSWeb. (QMS System)
--Assist with records management activities, including archive maintenance, coordination of document scanning, and on-and off-site storage
--Manages multiple tasks in a fast paced and dynamic environment while maintaining focus on quality and compliance with local SOPs, policies and directives, and regulatory requirements.
--Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
1-2 years of experience in the pharmaceutical industry, within Quality or Documentation function
Prior experience with Electronic Documentation Management System is preferred
Proficient in functions of Microsoft Word
Ability to work independently
Ability to work in a team environment
Attention to detail
Some overtime may be required
Remote with one day onsite in Billerica
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