Quality Specialist II - Temporary

Bio-Rad Laboratories • Hercules, CA

17h

About The Position

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 System to New Platform. The candidate works closely with 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.

Requirements

• 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)
• 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

Responsibilities

• 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
• 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.
• 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.
• 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
• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree