Senior QA Operations Specialist at Veeva
| East Bay | Remote
Sorry, this job was removed at 10:47 p.m. (CST) on Monday, January 3, 2022
Veeva [NYSE: VEEV] is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, our customers range from the world’s largest pharmaceutical companies to emerging biotechs. Veeva’s software helps our customers bring medicines and therapies to patients faster.
We are the first public company to become a Public Benefit Corporation. As a PBC, we are committed to making the industries we serve more productive, and we are committed to creating high-quality employment opportunities.
Veeva is a Work Anywhere company which means that you can choose to work in the environment that works best for you - on any given day. Whether you choose to work remotely from home or work in an office - it’s up to you.
The Sr. QA Specialist provides quality oversight to Veeva’s GxP product offerings, overseeing product change control, investigations, and CAPA. In addition, this role will support the Quality Operations function by reviewing and approving product validation deliverables (e.g., impacts assessment, plans, and summary reports).
What You'll Do
- Perform GxP/quality review of change control records, impact assessments, investigations, and validation artifacts.
- Coordinate investigations and CAPA records associated with product and infrastructure
- Project manage change process to ensure timely and accurate closure of changes to GxP products, tools, and environments.
- Conducts internal audits and associated reviews/analyzes data and documentation
- Support the management review process by monitoring Quality KPIs
- Responsible for creating and fostering mutually beneficial intradepartmental, cross-functional and organizational relationships to drive compliance to specified program objectives
- Bachelor’s degree in pharmaceutical sciences or other related scientific disciplines
- 5+ years of experience in a regulated industry with 3+ years of experience in pharmaceuticals, clinical research, and/or medical device
- Prior experience in the development and maintenance of a QMS system and operational experience
- Knowledge and understanding of 21CFR Part 11, 21CFR Part 211, 820, ISO standards, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMPs)
- Good working knowledge of CAPA/deviation, complaints, investigations, change control, document control methodologies, and associated procedures
- Proficiency in MS Office
Nice to Have
- Familiarity with Agile Software development
- Computer Systems Compliance and validation
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [email protected]