Quality Specialist II - Temporary jobs in United States
cer-icon
Apply on Employer Site
company-logo

Bio-Rad Laboratories · 1 week ago

Quality Specialist II - Temporary

Bio-Rad Laboratories is a global leader in developing and marketing high-quality research and clinical diagnostic products. The Quality Specialist II role involves supporting Quality Operations through hands-on engagement and oversight, ensuring compliance with quality standards while performing batch record reviews, product releases, and participating in audits.

BiotechnologyHealth CareHealth Diagnostics
check
H1B Sponsor Likelynote

Responsibilities

Driving Compliance and Risk Mitigation: QA Specialist IIIs are instrumental in ensuring that products and processes meet regulatory and internal quality standards
Enhancing Product and Process Quality: By reviewing batch records, managing quality documentation, and participating in root cause analysis, QA Specialist IIIs help identify and correct systemic issues
Acting as Subject Matter Experts: QA Specialist IIIs are designated as the primary experts for specific product regulatory compliance, in accordance with ISO13485 standards
Supporting Internal /External Audits - They play a key role in audit readiness , in the Bio-Rad requalification process, QA specialists coordinated responses to audit requests and ensured timely delivery of quality documentation
Strategic Quality Planning- working independently while collaborating across departments. They audit and review quality data, implement standards, and document results in regulated formats

Qualification

ISO 13485GMP standardsQuality Management SystemBatch record reviewDeviation managementSAPVeevaMicrosoft OfficeAttention to detailTime managementCommunication skills

Required

Associate degree or equivalent in Biology, Chemistry, or a related field
2+ years of experience in a regulated manufacturing industry, or an equivalent combination of education and experience
Familiarity with GMP and quality system standards (e.g., ISO 13485, FDA 21 CFR 820/210/211)
Working knowledge of device/drug/biotech manufacturing processes
Experience with nonconformance investigations, deviation management, batch record review, and product release
Proficiency in QMS databases, SAP, Veeva and Microsoft Office
Strong attention to detail, multitasking, time management, and communication skills

Company

Bio-Rad Laboratories

company-logo
Bio-Rad Laboratories has played a leading role in the advancement of scientific discovery for over 50 years by providing a broad range of

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 Company
Total Funding
$1.4B
2024-02-14Post Ipo Debt· $200M
2022-03-02Post Ipo Debt· $1.2B
1980-03-01IPO

Leadership Team

leader-logo
Christine A. Tsingos
EVP & CFO
linkedin
leader-logo
Jonathan Divincenzo
President and Chief Operating Officer
linkedin
Company data provided by crunchbase