Document Control Specialist - Software Guidance & Assistance, Inc. (SGA, Inc.) : Job Details

Software Guidance & Assistance, Inc., (SGA), is searching for a Document Control Specialist for a Contract assignment with one of our premier Healthcare clients in Boston, MA.

Responsibilities :

• Participates in global compliance and continuous improvement projects related to Quality System documentation.
• Ensures compliance during QS documentation creation and revision and is accountable for content design and logistics of multi- and cross-functional documentation review and approval.
• Supports development of strategy for creation of complex QS procedural documents involving cross-functional teams.
• Ensures all administrative documentation requirements are met for supported Quality Documentation inclusive of document processing and records management.
• Facilitates the creation/revision, administration, review, and approval (as applicable) of new and revised Quality Documentation within the Document Management System (DM)
• Maintains notifications, relations, and other property information within the Document Management System (DMS).
• Participates in supporting R&D project and initiatives and continuous improvement projects related to documentation management as applicable.
• Supports and coordinates of document translation process (incl. Translation checking (LU only) as applicable.
• Collects and reports documentation-related key performance indicator metrics.
• Provide input into overall team strategy and framework development for new and emerging initiatives (incl. mid- and long-term team goals).

Required Skills:

Bachelor's degree (technical/scientific area preferred) or equivalent experience.Minimum 4+ years of pharmaceutical experience in a GMP environment administering Document Control Systems1-2 years' experience using and administering electronic document management tools.​