Quality Documentation Specialist – QDS 0514 VG#01 Position Available In Wake, North Carolina
Tallo's Job Summary: A Quality Documentation Specialist role is available at NavitsPartners in Durham, NC. This position involves managing electronic and physical documentation processes for compliance with GMP and internal quality standards. Key responsibilities include working within Veeva Vault and SAP, supporting audits, and maintaining GMP standards. Requirements include a Bachelor's degree and 2 years of experience in a GMP-regulated environment.
Job Description
Quality Documentation Specialist – QDS 0514 VG#01
NavitsPartners Cary, NC Job Title:
Quality Documentation Specialist Location:
Durham, NC Contract Duration:
1 Year (Initial)
Work Arrangement:
Onsite Position Overview:
A leading GMP-regulated organization is seeking a Quality Documentation Specialist to join their Quality Systems team onsite in Durham, NC. This role involves managing both electronic and physical documentation processes to ensure ongoing compliance with Good Manufacturing Practices (GMP) and internal quality standards.
Key Responsibilities:
Maintain and manage controlled documents within Veeva Vault , including creation, revision, routing, approval, and archival. Support document check-out, re-issue, and resolution workflows through Veeva. Organize and handle physical documents stored onsite in the documentation room. Collaborate with Quality and Manufacturing teams to ensure documents accurately reflect operations and support compliance initiatives. Use PRIMS Record Inventory Management System for physical record tracking and inventory. Operate within SAP for document workflow management, material tracking, and inventory updates. Prepare documentation for internal and external audits, ensuring records are accurate, up-to-date, and audit-ready. Uphold GMP standards and contribute to a constant state of inspection readiness in all documentation activities.
Required Qualifications:
Bachelor’s degree in Life Sciences, Quality, or a related discipline (preferred). Minimum of 2 years’ experience in a documentation or quality support role within a GMP-regulated environment . Proficient with Veeva Vault , SAP , and documentation systems such as PRIMS . Strong organizational skills, attention to detail, and effective communication abilities. Ability to work onsite full-time and manage physical documentation responsibilities.
