Documentation Specialist - I (Assistant)

Title:

Documentation Specialist -

I Location:

Durham, NC 27712

Duration:

6+

Months Qualifications:

Bachelor's degree preferred; Associate degree or High School Diploma with 2+ years of GMP biopharmaceutical experience accepted. Experience with Veeva or other electronic document management systems (eDMS). Knowledge of GMP regulations and Good Documentation Practices (GDP). Experience archiving, organizing, and managing physical and electronic documents. Proficient in data entry with strong computer skills and attention to detail. Excellent written and verbal communication skills. Strong organizational, collaboration, and problem-solving abilities. Ability to identify and escalate issues appropriately while maintaining compliance.

Responsibilities:

Issued and reconciled controlled documents using the Veeva electronic document management system. Assisted with document archiving and retrieval in the High Density Storage Room (HDSR). Updated and maintained archived paper records in the PRIMS Record Inventory Management System. Organized, issued, and reconciled paper batch records generated from SAP. Ensured compliance with Good Documentation Practices (GDP) when entering and maintaining documentation. Supported system owners in maintaining an inspection-ready state for regulatory and internal audits. Processed document check-in/check-out requests and maintained accurate document inventory records. Guided internal stakeholders on Quality System procedures and documentation processes to ensure compliance. Maintained accurate quality documentation in accordance with GMP, site procedures, and global quality standards. Collaborated with cross-functional teams to support quality systems and document control activities in a regulated biopharmaceutical environment.