Quality Specialist II

Responsibilities

• Support Quality Operations through hands-on floor engagement and real-time support to manufacturing teams
• Perform batch record reviews, product releases, and review stability studies and labeling
• Chair Material Review Board (MRB) meetings and participate in Environmental Control Meetings
• Coordinate Quality Notifications (QNs) and support both internal and external audits
• Drive compliance and risk mitigation by ensuring products meet regulatory and internal quality standards
• Act as a subject matter expert for specific product regulatory compliance in accordance with ISO 13485
• Update quarterly quality metrics and assist in root cause analysis to identify systemic issues

Requirements

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

About the Company

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As a global leader in life sciences, we develop, manufacture, and market a broad range of high-quality research and clinical diagnostic products to help people everywhere live longer, healthier lives.