Synerfac is seeking a Document Control Specialist for our client in Devans, MA. Our client is a global leader in the development and manufacturing of specialist and complex active pharmaceutical ingredients for pharma and biotech customers.

The purpose of this position is to have a qualified individual who will be responsible for the design, implementation, and maintenance of the Quality Assurance Documentation Management.

This role will serve as administrator of current and future quality documentation systems and or software systems. - Issuance, tracking, and control of Standard Operating Procedures, Master Batch Records, Test Records, Forms, Protocols, Amendments, and Final Reports including formatting, editing, and revisions.

• Updating, maintaining and refining document control procedures and training other staff members on document control procedures- Filing, tracking and archiving GMP documentation.
• Establishing and maintaining records management system including secure storage, retrieval, retention and destruction.- Participating in and supporting quality audits (internal and external), troubleshooting efforts, and other Quality System.
• Collaborating with other members of the Quality group, in support of the development and revision of procedural documents.
• Writing and maintaining document control procedures and participating in the development / improvement and roll-out of document control tools.
• Assisting in review of cGMP-controlled documents as necessary.- Overseeing the quality review and consistency checks applied across the department, ensuring accuracy and clarity of content within and across documents.
• Ensuring global coverage for responding to urgent requests in a timely manner.- Managing and executing the routing, review, approval, distribution and archival of new and revised controlled documents.
• Minimum 3 years experience in a GMP / Regulated environment.- Knowledge of Quality Management System and Quality Events Management Systems.

Last updated : 2024-04-25