About the role: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.Key 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
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.
Educational Requirements: Training, Skills, Knowledge, and Qualifications: - 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.
Compensation and Benefits:
The base salary range for this position is $100,000-120,000 for San Diego,CA,. Benefits include 401K with company match, Flexible Vacation Policy, Health Benefits, Investment in Professional and Personal Development, and much more.
Biosero provides 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. In addition, Biosero complies with applicable state and local laws governing nondiscrimination in employment in every location in which it has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Biosero is committed to diversity and inclusion. We seek individuals from all backgrounds and appreciate and celebrate the diversity of our growing team.