Bio-Rad Laboratories · 8 hours ago
Quality System Specialist II
Hercules, CA
Full-time
Onsite
Mid Level
$77K/yr - $107K/yr
4+ years expBio-Rad Laboratories is a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. As a Quality System Specialist II, you will support manufacturing operations by overseeing product release, managing process nonconformance and deviation issues, and coordinating with departmental staff.
BiotechnologyMedical DeviceHealthcareHealth CareHealth Diagnostics
Hiring Manager
Angela Kane
Responsibilities
Review and approve batch records and related documentation
Support investigations for non-conformances and deviations
Collaborate with Operations to implement corrective and preventive actions
Maintain compliance with ISO, FDA, and other applicable regulations
Assist in internal audits and regulatory inspections
Escalate relevant issues to the right department for proper resolution
Correct processing of Deviations and Non- conformances
Rapid containment of product quality issues (either from manufacturing issue or a customer complaint issue)
Qualification
Required
Education: Associate degree or equivalent in Biology, Chemistry, or related field
Work Experience: 4+ years experience in a regulated industry or equivalent combination of education and experience
Self- driven: no need to be micro – managed and can have personal initiative to prioritize work activities
Team player: have general positive personality and work well with others, especially outside the department
Quality Mindset: Can understand the risk or impact of an issue to other process(es)
Regulatory: Able to understand GMP and regulatory requirements applicable to US FDA and ISO standards
Data- driven: Able to retrieve data and organize them, to allow for analysis and conclusion
Interested: Able to learn and eager to learn more about the product, process, workflows to foster an environment of continuous improvement
Detailed oriented and ability to multi- task based on priority
Preferred
SAP /Veeva/Power BI experience is a plus
Benefits
Competitive medical plans for you and your family
Free HSA funds
A new fertility offering with stipend
Group life and disability
Paid parental leave
401k 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)
Company
Bio-Rad Laboratories
Bio-Rad Laboratories has played a leading role in the advancement of scientific discovery for over 50 years by providing a broad range of
5001-10000 employees
H1B Sponsorship
Bio-Rad Laboratories has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (40)
2023 (41)
2022 (56)
2021 (45)
2020 (34)
Funding
Current Stage
Public CompanyTotal Funding
$1.4B2024-02-14Post Ipo Debt· $200M
2022-03-02Post Ipo Debt· $1.2B
1980-03-01IPO
Leadership Team
Christine A. Tsingos
EVP & CFO
Jonathan Divincenzo
President and Chief Operating Officer
Recent News
EIN Presswire
2026-01-20
Company data provided by crunchbase