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.

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $28.00/hr – $29.25/hr.