Sr. Quality Assurance Specialist

Biosero•San Diego, CA

9d•$100,000 - $120,000

About The Position

The Quality Assurance (QA) Specialist is responsible for supporting quality planning and ensuring compliance across production and operational processes within a regulated environment. This role works closely with manufacturing, engineering, and cross-functional teams to establish and maintain quality systems that meet applicable regulatory standards such as ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11. The QA Specialist oversees quality processes throughout the product lifecycle, including reviewing and approving validation and quality documentation, managing deviations, CAPAs, and change controls, and ensuring that production activities meet defined quality standards. The role also supports internal and external audits, participates in vendor qualification activities, and helps maintain compliance with regulatory and industry requirements. In addition, the position contributes to continuous improvement initiatives by monitoring quality metrics, supporting LEAN initiatives, and providing guidance and training on quality processes and compliance. The ideal candidate is detail-oriented, collaborative, and experienced in quality assurance within regulated manufacturing or life sciences environments, with a strong ability to ensure quality is built into planning, production, and operational workflows.

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.

Nice To Haves

Experience with electronic quality management systems (eQMS).
Familiarity with Agile and DevOps environments.
Certification in Quality Assurance or Regulatory Affairs (e.g., ASQ, RAPS) is a plus.
Experience in pharmaceutical, biotech, or medical device industries.

Responsibilities

Ensure compliance with applicable standards and regulations (ISO 9001, GAMP 5, EU GMP Annex 11, 21 CFR Part 11).
Review and approve validation documentation (e.g., URS, FRS, test protocols, test scripts).
Conduct and support internal and external audits, including regulatory inspections.
Develop, implement, and maintain QA policies, procedures, and SOPs.
Perform risk assessments and support risk-based decision-making.
Monitor and report on quality metrics and KPIs.
Provide training and guidance on quality and compliance topics to cross-functional teams.
Manage deviations, CAPAs, change controls, and other quality records.
Participate in vendor qualification and software supplier audits.
Stay current with regulatory developments and industry best practices.
Support the LEAN work in the company