Overview
A typical day for the Quality Specialist II is centered on executing and supporting the full lifecycle migration of the Quality Management System from Legacy Sytem to New Platform.. The candidate works closely all cross-functional stakeholders to map existing Legacy documents and records into New Platform, configure document hierarchies and metadata, and validate migrated content for accuracy and compliance. They facilitate user acceptance testing (UAT), resolve migration discrepancies, and ensure that all controlled documents remain accessible and audit-ready throughout the transition.
This role also involves training end-users , supporting the decommissioning of Legacy System, and maintaining regulatory compliance (ISO 13485, FDA 21 CFR 820) at every stage of the migration. The candidate collaborates daily with the QA team, project managers, and system administrators to track migration progress, escalate issues, and ensure the integrity of the quality documentation ecosystem during and after cutover.
How You'll Make An Impact:
- Leading QMS Migration: Spearheading the end-to-end transition of quality documentation, SOPs, and records ensuring data integrity, minimal operational disruption, and full regulatory compliance throughout the migration lifecycle
- Facilitating Cross-Functional Migration Meetings: Leading and coordinating stakeholder meetings across QA, , Regulatory, and Operations to review migrated documentation, align on content accuracy, resolve discrepancies, and track migration milestones to ensure timely project completion.
- Performing Gap Assessments on Legacy Documentation: Conducting structured gap analyses on legacy documents to identify compliance deficiencies against IVDR requirements, prioritizing remediation efforts, and ensuring all migrated content meets current regulatory standards before go-live.
- Driving System Validation and User Adoption: Supporting UAT activities, documenting test results, and training end-users on Veeva Quality Docs workflows to ensure a smooth cutover and sustained system compliance post-migration
- Supporting Decommissioning and Audit Readiness: Coordinating the controlled retirement Legacy platform, maintaining documentation traceability during transition, and ensuring the quality system remains inspection-ready for internal and external audits throughout the migration period
What You Bring:
- Associate degree or equivalent in Biology, Chemistry,Engineering or a related field
- 3+ 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) 1 2.
- Working knowledge of device/drug/biotech manufacturing processes.
- Proficiency in QMS databases , SAP, Veeva and Microsoft Office
- Strong attention to detail, project coordination skills, and the ability to manage multiple workstreams simultaneously while collaborating cross-functionally and influencing without authority during a system transition
Compensation: The estimated hourly range for this position is $40 to $43 per hour 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. As a temporary associate, your employment will be managed directly through our approved agency provider.
Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.
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.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes
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