Documentation Specialist - I

Summary
We are seeking a Documentation Specialist I to support Quality Systems Documentation Management at a GMP biopharmaceutical facility. This on-site contract role will be focused on document issuance, reconciliation, and archiving using electronic systems such as Veeva and PRIMS. The specialist will play a critical role in maintaining site inspection readiness and supporting compliance with documentation procedures in a highly regulated environment.

Responsibilities
• Issue and reconcile documents using an electronic document management system (Veeva).
• Provide archiving assistance in the High Density Storage Room (HDSR).
• Maintain and update records in the Record Inventory Management System (PRIMS).
• Organize and prepare paper batch records from SAP for issuance.
• Ensure Good Documentation Practices (GDP) during data entry and record handling.
• Support system owners in maintaining site inspection readiness.
• Guide staff on appropriate Quality System procedures and documentation processes.
• Adhere to all global and site-specific documentation and compliance procedures.
• Perform check-out and archiving of paper documents as required.
• Support general quality documentation tasks as assigned.

Education
• Bachelor’s degree preferred
• Associate’s degree or High School Diploma accepted with minimum 2 years of related GMP biopharma experience

Experience
• At least 2 years of relevant experience in a GMP biopharma environment
• Experience with electronic document management systems (Veeva)
• Familiarity with archiving physical documents and using systems like PRIMS
• Strong data entry and computer skills
• Understanding of Good Documentation Practices (GDP) and quality systems

Additional Information
• Full-time, on-site contract position
• Must adhere to global and site procedures related to quality and documentation
• Candidates must be comfortable working in a structured, compliance-driven environment