Quality Assurance Specialist - Document Control, CVRM

Genentech • Holly Springs, NC

2d • Onsite

About The Position

The Quality Assurance Specialist - Document Control is a detail-oriented role responsible for the integrity, accessibility, and compliance of quality and operational documents at Roche/Genentech’s Holly Springs, North Carolina manufacturing site. The specialist manages document lifecycles and archival operations, partners with cross-functional teams, and helps establish standardized document control practices and a culture of document excellence across the site.

The role serves as a subject matter expert in Veeva Quality Documents, maintaining and troubleshooting workflows, templates, and document hierarchies. It supports tailored workflows for different functions, leads system best-practice training, and ensures documentation processes comply with global GxP standards. The specialist also manages filing structures, retrieval systems, metadata, document metrics, the site archival room, and the document retention program. This includes overseeing records transitions, audits, retrieval, and destruction, and supporting inspections, management reviews, and health authority engagement.

The position is based at the Holly Springs site. Relocation assistance is not available. The expected salary range is $77,500–$143,900, with actual pay determined by experience, qualifications, geographic location, and other job-related factors. A discretionary annual bonus may be available based on individual and company performance. The position qualifies for benefits detailed at the provided link.

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.
• Demonstrated 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 records retention scheduling and legacy document management.
• Deep knowledge of global GxP regulations, including FDA, EMA, ICH, and ISO, and their practical application to document control in pharmaceutical manufacturing.
• 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 excellent time management, with the ability to manage multiple priorities in a fast-paced environment.
• Exceptional 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 fostering 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.
• Collaborate with Engineering, MS&T, QC, and Operations to design Veeva workflows suited to their documentation needs while maintaining compliance.
• Lead training initiatives on Veeva Quality Documents best practices.
• Partner with cross-functional teams 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; and manage document destruction according to retention schedules and policies.
• Partner with Engineering, MS&T, QC, Quality Assurance, Operations, and Regulatory Affairs on retention needs, document control oversight, compliance, and continuous improvement.
• Support inspections, management reviews, and health authority engagement.
• Communicate documentation risks and compliance gaps to cross-functional leaders and escalate issues to drive timely resolution.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for benefits detailed at the link provided in the job posting.

What This Job Offers

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