Document Controls Specialist

Summary:
Processes change requests and controlled documents in electronic system to ensure that process and documentation changes with the potential to impact the safety, purity, potency, and quality of manufactured product are thoroughly reviewed, justified, documented, approved, and implemented in conformance with regulatory requirements and company policies / procedures.

• 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.

• Bachelor's degree in a scientific field