Sr. Quality Assurance Specialist

BioseroSan Diego, CA

$100,000 - $120,000 / year

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Overview

Schedule

Full-time

Education

Engineering (PE)

Career level

Senior-level

Compensation

$100,000-$120,000/year

Benefits

Health Insurance

Paid Vacation

Flexible/Unlimited PTO

Job Description

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:

Bachelor’s or master’s degree in Life Sciences, Computer Science, Engineering, or related field.
Experience in lieu of degree will be considered, preferably with some knowledge of lab automation and scheduling software

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.

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FAQs About Sr. Quality Assurance Specialist Jobs at Biosero

What is the work location for this position at Biosero?

This job at Biosero is located in San Diego, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Biosero?

Candidates can expect a pay range of $100,000 and $120,000 per year.

What employment applies to this position at Biosero?

Biosero lists this role as a Full-time position.

What experience level is required for this role at Biosero?

Biosero is looking for a candidate with "Senior-level" experience level.

What is the process to apply for this position at Biosero?

You can apply for this role at Biosero either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.