Quality Assurance Specialist - Document Control, CVRM

Genentech • Cary, NC

2d • $77,500 - $143,900

About The Position

The Quality Assurance Specialist - Document Control, CVRM role is based at Genentech’s Holly Springs, North Carolina facility, a planned high-volume drug product manufacturing site scheduled to launch in 2028. The position supports the site’s quality and operational documentation systems and helps establish document stewardship practices as the facility is brought online.

As a member of the Document Control team, the specialist manages document lifecycles and archival operations and partners with Engineering, MS&T, Quality Assurance, Quality Control, Operations, Regulatory Affairs, and other teams. The role focuses on maintaining compliant and accessible documentation, standardizing document practices, supporting continuous improvement, and serving as a central resource for site-wide documentation standards.

The specialist serves as a subject matter expert for Veeva Quality Documents, supporting system workflows, templates, hierarchies, user training, and cross-functional documentation needs. The position also owns the site archival room and document retention program, including records organization, retrieval, audits, archival transitions, and compliant document destruction. The role supports inspections, management reviews, and health authority engagement, and communicates documentation risks and compliance gaps to leaders.

The expected salary range for the Holly Springs location is $77,500–$143,900. Actual compensation depends on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. Relocation assistance is not available. The position qualifies for benefits detailed at a link in the posting; specific benefits are not listed.

Requirements

• Bachelor's degree in a scientific or technical discipline.
• 5–8 years of experience in a GxP environment, including at least 3 years of accumulated experience in document control, records management, or quality documentation at a manufacturing site.
• Expertise in Veeva Quality Documents system administration and user support, including workflow configuration and data management.
• Hands-on experience organizing and managing physical or hybrid document archival rooms, including retention scheduling and legacy document management.
• Knowledge of global GxP regulations, including FDA, EMA, ICH, and ISO, and their practical application to pharmaceutical manufacturing document control.
• Experience translating regulatory documentation requirements into practical standard operating procedures and control processes.
• Demonstrated success developing, implementing, or auditing site-wide document control compliance programs.
• Strong organizational skills, meticulous attention to detail, and time management skills, with the ability to manage multiple priorities in a fast-paced environment.
• Excellent cross-functional communication and collaboration skills, including the ability to build relationships with Quality, QC, Operations, Engineering, MS&T, Regulatory Affairs, and global teams.
• Proactive problem-solving skills, including anticipating documentation gaps, escalating issues with appropriate context, and supporting transparent, solution-oriented dialogue.
• Ability to work in a dynamic environment while maintaining high quality and compliance standards.

Responsibilities

• Serve as a subject matter expert in Veeva Quality Documents.
• Maintain and troubleshoot Veeva Quality Document workflows, templates, and document hierarchies for document creation, review, approval, and distribution.
• Work with Engineering, MS&T, QC, and Operations to design Veeva workflows that meet functional needs while maintaining compliance.
• Lead training on Veeva Quality Documents best practices and system capabilities.
• Partner with Engineering, MS&T, QC, Quality Assurance, and Operations to ensure quality, regulatory, and operational documents follow control procedures and global GxP standards.
• Establish and maintain standardized document filing structures, retrieval systems, and metadata standards.
• Monitor document metrics, including approval timeliness, periodic reviews, and archival accuracy.
• Own the site archival room and document retention program, including procedures for indexing, storage, retrieval, and records classification.
• Coordinate the transition of records from active management to archival status.
• Conduct periodic audits of archival organization and accessibility.
• Manage document destruction in accordance with retention schedules and organizational policies.
• Partner with cross-functional teams to understand retention needs, promote document control practices, oversee document control systems, and support continuous improvement.
• Support compliance processes, including inspections, management reviews, and health authority engagement.
• Communicate documentation risks and compliance gaps to cross-functional leaders and escalate issues for timely resolution.

Benefits

• The position qualifies for benefits detailed at a link provided in the posting; individual benefits are not specified.
• A discretionary annual bonus may be available based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level