Sr. Quality Assurance Specialist
BioseroSan Diego, California, United States
Posted March 13, 2026
100000 - 120000 USD
Full Time
About the Company
Biosero is a company committed to diversity and inclusion, providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
Job Description
The Sr. Quality Assurance Specialist is responsible for ensuring compliance across production and operational processes within a regulated environment, working closely with manufacturing, engineering, and cross-functional teams to establish and maintain quality systems that meet applicable regulatory standards.
Requirements
- Minimum 5 years of experience in QA within a regulated software development environment.
- Experience working with LEAN
- Strong knowledge of ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
- Experience with validation of computerized systems and software quality assurance.
- Excellent understanding of SDLC and software testing methodologies.
- Strong analytical, problem-solving, and communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Fluent in English (written and spoken); additional languages are a plus.
Benefits
- 401K with company match
- Flexible Vacation Policy
- Health Benefits
- Investment in Professional and Personal Development
