Senior Quality Assurance Specialist
Genentech • Cary, NC12d • $94,000 - $174,600 • Onsite
Quality Specialist Jobs
2,705 jobs found — updated daily
Customer Quality Engineering Specialist
ABB • Senatobia, MS12d • $68,600 - $109,760Quality Assurance Specialist
Virginia Information Technologies Agency • Hanover, VA12d • $72,491 - $86,044 • OnsiteSenior Quality Assurance Specialist
Roche • Holly Springs, NC12d • $94,000 - $174,600 • OnsiteInventory Control Quality Assurance Specialist
C&S Wholesale Grocers • Plant City, FL12d • OnsiteRN Clinical Risk and Safety Specialist
ProMedica • Toledo, OH12dSpecialist, Quality Engineer
L3Harris Technologies • Huntsville, AL12d • OnsiteSenior Quality Automation Specialist
State Street • Quincy, MA12d • $90,000 - $157,500 • HybridQuality Systems Specialist
Swanson Health • Fargo, ND12dQuality Specialist
Servco Pacific Inc. • Kaneohe, HI12d • $25 - $26Quality Specialist
Mount Sinai Medical Center • Hialeah, FL12dSpecialist, Quality and Regulatory Operations
Cencora • Corona, CA12d • $52,000 - $81,620 • OnsiteWater Quality Specialist
Summers of Brownsburg Inc • Noblesville, IN12dQuality Specialist
Brown Medicine • Baltimore, MD12d • $22 - $36 • RemoteSpecialist Quality Engineer
L3Harris Technologies • Greenville, TX12d • OnsiteCompliance Specialist
APTIM • New York, NY12d • $87,000 - $99,000Lead Quality Assurance Specialist
Defense Contract Management Agency • Gladstone, MO12dQuality and Compliance Specialist
Access Services • Bethlehem, PA12d • HybridLX Senior Content Quality Specialist
GP Strategies • Troy, MI12dQuality and Compliance Specialist
Access Services • Plymouth Meeting, PA12d • Hybrid
Senior Quality Assurance Specialist - Digital Apps (CVRM)
Genentech•Cary, NC
•$94,000 - $174,600•Onsite
About The Position
Genentech seeks a Senior Quality Assurance Specialist, Digital Apps, to serve as the technical and compliance anchor for digital Quality applications at its Holly Springs, North Carolina site. The role ensures QA IT-owned systems are properly configured and maintained to support site operations and helps embed a robust, risk-oriented Quality Culture into the site's operational design. The facility is a planned high-volume drug product manufacturing site focused on CVRM medicines, with a planned launch in 2028. The specialist leads configuration, maintenance, implementation oversight, testing, validation, and compliance activities for QA-owned digital systems. The position includes SAP Quality workflow and master data management, support for digital applications such as Speca, Batch Release Hub, and Tulip, and a particular focus on automated batch release and CoA generation. The role also supports computer systems validation, end-user training, investigations and change processes, and the creation and approval of quality documentation. The position is based in Holly Springs, North Carolina. Relocation assistance is not available. The expected salary range is $94,000–$174,600, with actual pay determined by 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. The role qualifies for benefits detailed at a link referenced in the posting.
Requirements
- Bachelor's degree in a scientific, technical, or information systems discipline.
- Minimum of 6–8 years of experience in a GxP environment, including 3+ years managing setup and maintenance of QA digital applications.
- In-depth understanding of IT architecture, system interfaces, and end-to-end data flows to optimize operational workflows.
- Expertise in SAP master data governance, optimization, and life cycle management.
- Working knowledge of manufacturing operations, specification management, product release, and change and exception handling from an IT systems and applications perspective.
- Strong GMP and CSV expertise, including comprehensive knowledge of global regulatory requirements, including EU-GMP Annex 11 and Chapter 4 expectations.
- Hands-on experience configuring and administering SAP Quality modules and associated master data.
- Experience supporting health authority inspections and regulatory audits.
- Strong cross-functional leadership skills and ability to influence stakeholders and global partners without direct authority.
- Comfort with ambiguity and proficiency applying Lean/Six Sigma principles to improve process efficiency and compliance.
- Ability to work in fast-paced environments while maintaining commitment to quality and compliance standards.
Nice To Haves
- Advanced degree preferred.
Responsibilities
- Lead configuration, routine maintenance, and compliance oversight of QA-owned digital systems and applications.
- Oversee local IT system implementation strategies to align with project timelines and operational goals.
- Execute system testing during initial deployments and periodic system updates.
- Configure SAP Quality workflows and establish, maintain, and validate master data for site-wide quality operations.
- Configure digital applications, including Speca, Batch Release Hub, and Tulip, with a focus on automated batch release and CoA generation.
- Provide Quality oversight for custom Tulip digital applications, ensuring adherence to data integrity and digital application standards.
- Provide QA oversight and support to applications owned by other site functions.
- Support computer systems validation (CSV) activities across digital applications.
- Drive end-user training programs for supported digital systems.
- Own deviation investigations, CAPAs, and Change Requests; perform periodic reporting, system evaluations, and audit trail reviews; and serve as the local system administrator.
- Author, review, and approve SOPs, work instructions, monitoring protocols and reports, gap assessments, and risk assessments.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- The position qualifies for company benefits detailed at the link referenced in the posting.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Senior
Job Search Resources
Build a Resume for Quality Specialist
The resume builder that gets results.
- Get clear feedback so you look as qualified as you are
- Align your resume with the job to get further in the process, faster
- Take the guesswork out of resume writing
