Quality System Specialist II

Tri-Valley Career Center; Richmond (CA); On-site; USD 77,600 - 106,700; Full time

Job summary

Bio-Rad Life Science Group in Richmond, CA is seeking a Quality System Specialist II to support product release, deviation management, and QA initiatives. The role collaborates with Manufacturing, reviews batch records, and contributes to change control, audit support, and CAPA activities.

Based in Hercules with commute to the office, you’ll help ensure regulatory compliance and product quality. The ideal candidate has GMP/regulatory knowledge, 4+ years in a regulated setting, strong data

Qualifications

• Associate degree or equivalent in Biology, Chemistry, or related field.
• 4+ years experience in a regulated industry.
• Understanding of GMP and regulatory requirements (US FDA, ISO).
• Ability to retrieve, organize, and analyze data to inform decisions.
• Willingness to learn product, process, and workflows for continuous improvement.

Responsibilities

• Timely product releases from manufacturing to distribution.
• Escalate issues to the right department for proper resolution.
• Correct processing of Quality Notifications (Deviations and Non-conformances).
• Support regulatory and customer audits, including inspection preparation and responses.
• Rapid containment of product quality issues from manufacturing or customer complaints.

Skills

GMP knowledge

Regulatory knowledge

Data analysis

SAP

Detail oriented

Education

Associate degree or equivalent

Tools

SAP

Job description

The Quality System Specialist II will play a key role in supporting manufacturing activities at the Life Science Group site on the Richmond campus. The role primarily involves supporting product release and process nonconformance and deviation management, including follow‑up and liaison with applicable department assignees. The day starts with a meeting with Manufacturing to understand daily objectives. Batch record review and the quality notification process occupy roughly 75% of a typical day, with the remaining 25% divided among change control, complaint support, audit support, and other QA initiatives.

How You’ll Make An Impact

• Timely product releases from manufacturing to distribution
• Escalate relevant issues to the right department for proper resolution
• Correct processing of Quality Notifications (Deviations and Non‑conformances)
• Support regulatory and customer audits, including inspection preparation activities and audit responses
• Rapid containment of product quality issues, whether from manufacturing or customer complaints

What You Bring

• Education: Associate degree or equivalent in Biology, Chemistry, or a related field.
• Work Experience: 4+ years experience in a regulated industry or equivalent combination of education and experience.
• Self‑driven: Managed, not micro‑managed, with personal initiative to prioritize work activities.
• Team player: Positive personality and works well with others, especially outside the department.
• Quality mindset: Able to understand the risk or impact of an issue on other processes.
• Regulatory: Able to understand GMP and regulatory requirements applicable to US FDA and ISO standards.
• Data‑driven: Able to retrieve, organize, and analyze data to reach conclusions.
• Interested: Eager to learn more about the product, process, and workflows to foster continuous improvement.
• Detail oriented and able to multi‑task based on priority.
• SAP experience is a plus.

Location

This position must be based in Hercules, CA and requires the employee to be located within commuting distance of the office.

Total Rewards Package

At Bio‑Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio‑Rad’s robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

Benefits

We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401(k) plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more!

Compensation

The estimated base salary range for this position is $77,600 to $106,700 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job‑permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

EEO Statement

Bio‑Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.