Documentation Specialist (Biopharma)

TL;DR

Documentation Specialist (Biopharma): Managing and reconciling quality documentation within an electronic system with an accent on GMP compliance and physical archiving. Focus on maintaining site inspection readiness, updating record inventory systems, and ensuring adherence to Good Documentation Practices.

Location: Must be based in Durham, NC

Salary: $55,700–$60,800

Company

hirify.global is a staffing agency providing professional placement services across various technical and scientific industries.

What you will do

• Issue and reconcile documents using the Veeva electronic document management system.
• Assist with archiving and organizing physical documents in the High-Density Storage Room.
• Update the Record Inventory Management System (PRIMS) for archived paper records.
• Support system owners in maintaining site inspection readiness.
• Organize paper batch records from SAP for issuance.
• Ensure strict adherence to Good Documentation Practices (GDP) during data entry.

Requirements

• Must be based in or able to work in Durham, NC.
• Bachelor’s degree preferred, or Associate degree/High School Diploma with 2 years of related GMP Biopharma experience.
• Proficiency with Veeva or similar electronic document management systems.
• Experience with archiving and organizing physical documentation.
• Strong data entry and computer skills.
• Excellent written and verbal communication skills.

Culture & Benefits

• Major medical, dental, and vision insurance for assignments lasting 13 weeks or longer.
• 401k retirement plan participation.
• Statutory sick pay where required by law.
• Commitment to reasonable accommodations for individuals with disabilities.