Medasource · 1 month ago
Quality Assurance Document Controller
Durham, NC
Full-time
Onsite
Entry Level
1+ years expMedasource is a company focused on document management in the pharmaceutical sector. The QA Document Controller role involves supporting document management for GMP documentation, ensuring compliance, and facilitating various document control activities.
Health CareMedical
Hiring Manager
Jenna Kimack
Responsibilities
Maintain Client Library Site document inventory control through the Record Manager (LRM) system in accordance with applicable SOPs
Ensure accurate control and tracking of all GMP documents
Perform document control activities for all Client Site documents and records maintained in Client’s Veeva Quality Docs Electronic Data Management System (EDMS)
Complete all required Client training and maintain compliance with documentation and records management procedures
Assist with routing, updating, and approval of electronic documents according to applicable SOPs and Client personnel requirements
Manage and monitor assigned Veeva Vault Quality Docs workflows daily
Meet with internal personnel as needed to review documents and update Veeva Quality Docs metadata when adding documents into the system
Manage retention of GMP records in accordance with document type, record class codes, and Client retention policies
Prepare and manage shipment of records to off-site storage for long-term retention when required
Facilitate the reconciliation process for executable electronic and paper records according to applicable SOPs
Oversee and complete annual department signature logs
Bind, issue, and maintain physical logbooks; support reconciliation of paper logbooks per SOP requirements
Label and code files for storage in on-site Documentation Centers
Support internal and external audits by providing readily accessible records
Assist with additional staffing or extended hours if requested in relation to audits, in alignment with Work Order terms
Support self-inspections by ensuring documentation and records are compliant and accessible within Veeva Vault EDMS
Monitor and conduct periodic document reviews per SOPs and management direction
Work closely with Quality, Learning and Development, and other site business areas to capture and support document needs
Periodically update documents in accordance with applicable SOPs
Escalate issues to contractor leads or Client management as appropriate
Follow all applicable Client GMP Standard Operating Procedures and report any compliance concerns in a timely manner
Qualification
Required
BA/BS degree or equivalent experience
General understanding of basic GDP principles and GMP environments
Strong proficiency with Microsoft Office applications
Familiarity with office equipment (copier, scanner, fax, etc.)
Proficient with Document Routing System workflow functionality
Ability to climb stairs, bend, and reach for filing; lift up to 30 lbs. as needed to move/organize file boxes
Preferred
1–3 years of relevant experience in the pharmaceutical/biopharmaceutical industry
Company
Medasource
Medasource is a hospital & health care company specializing in population health management and clinical engineering services.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Abimbola ojo
EPIC OPTIME/ ANESTHESIA Consultant at Ascension
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