Belcan · 9 hours ago
Document Control Specialist
Durham, NC
Full-time
Onsite
New Grad, Entry Level
$39/hr - $42/hrBelcan is seeking a Document Control Specialist to assist in managing document control processes. The role involves ensuring compliance with FDA regulations, processing change requests, and maintaining documentation related to manufacturing processes.
Enterprise SoftwareIndustrial EngineeringProject ManagementSoftwareTechnical Support
Hiring Manager
Mohan M.
Responsibilities
Ensures compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to change and document control
Processes change control request documentation related to cGMP manufacturing processes and SOPs for plasma centers and plasma operations, including but not limited to: product manufacturing / procedural changes, equipment changes, customer changes, supplier (contractor) changes, and facility changes
Tracks and maintains change control request documentation throughout its lifecycle to ensure tasks are completed in a timely manner
Coordinates change control process to ensure timely delivery of change requests and information to customers, including plasma centers and plasma operations, as required
Communicates with other departments, including Corporate, Field management, and Center-level customers to ensure efficient flow of change requests and information pertaining to shared/impacted processes
Reviews / evaluates supporting document content and formatting for all change requests. Facilitates with change requestors, change owners, and reviewers to resolve concerns prior to and during implementation of the change
Prepares changes for review, and engages leadership and subject matter experts as needed to facilitate the change control process
Performs final review of change requests and its documentation to ensure completeness, including documented evidence of impact assessments as a part of risk management and completion of all actions required by the change have occurred. Coordinates training on Change Control procedures
Responds to customer service requests, and assists other departments, as needed
Maintains a master library/database of all change request documents. Maintains secured filing and storage system for archived hard copy change requests
Manages Quality System documentation throughout its lifecycle to process, distribute and track. Maintains Quality System documentation through creation/revision, review and approval, effectivity, and obsolescence. Distributes customer specification documents to departments and point-of-use locations
Maintains electronic document control system (i.e., DCM), and controls electronic versions of documents and archived files that exist outside of the electronic document control system
Prepares/proofs document content and formatting for all documents. Coordinates with document authors, owners, and reviewers to resolve content and formatting concerns prior to issue
Maintains a master library/database of all SOPs, forms, job aids, and training documents. Maintains secured filing and storage system for archived hard copy controlled documentation
Maintains document control calendars and databases, and ensures document control procedures are updated according to established procedures and standards
Authors Center Notifications as needed to communicate non-procedural updates to the donor centers and leadership
Qualification
Required
Bachelor's degree in a scientific field
Ensures compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to change and document control
Processes change control request documentation related to cGMP manufacturing processes and SOPs for plasma centers and plasma operations, including but not limited to: product manufacturing / procedural changes, equipment changes, customer changes, supplier (contractor) changes, and facility changes
Tracks and maintains change control request documentation throughout its lifecycle to ensure tasks are completed in a timely manner
Coordinates change control process to ensure timely delivery of change requests and information to customers, including plasma centers and plasma operations, as required
Communicates with other departments, including Corporate, Field management, and Center-level customers to ensure efficient flow of change requests and information pertaining to shared/impacted processes
Reviews / evaluates supporting document content and formatting for all change requests. Facilitates with change requestors, change owners, and reviewers to resolve concerns prior to and during implementation of the change
Prepares changes for review, and engages leadership and subject matter experts as needed to facilitate the change control process
Performs final review of change requests and its documentation to ensure completeness, including documented evidence of impact assessments as a part of risk management and completion of all actions required by the change have occurred. Coordinates training on Change Control procedures
Responds to customer service requests, and assists other departments, as needed
Maintains a master library/database of all change request documents. Maintains secured filing and storage system for archived hard copy change requests
Manages Quality System documentation throughout its lifecycle to process, distribute and track. Maintains Quality System documentation through creation/revision, review and approval, effectivity, and obsolescence. Distributes customer specification documents to departments and point-of-use locations
Maintains electronic document control system (i.e., DCM), and controls electronic versions of documents and archived files that exist outside of the electronic document control system
Prepares/proofs document content and formatting for all documents. Coordinates with document authors, owners, and reviewers to resolve content and formatting concerns prior to issue
Maintains a master library/database of all SOPs, forms, job aids, and training documents. Maintains secured filing and storage system for archived hard copy controlled documentation
Maintains document control calendars and databases, and ensures document control procedures are updated according to established procedures and standards
Authors Center Notifications as needed to communicate non-procedural updates to the donor centers and leadership
Preferred
extensive Word formatting tools experience
some Documentation management tool experience
Company
Belcan
Belcan is a engineering services company offering design, manufacturing, and IT solutions for aerospace, defense, automotive, and more.
Founded in 1958
5001-10000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-06-10Acquired
Leadership Team
Dave Brandel
President & COO, Engineering Solutions
David Moya
DIRECTOR OF OPERATIONS
Recent News
2026-01-22
2025-10-31
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