Quality System Specialist II

Responsibilities

• Support manufacturing activities through timely product release from manufacturing to distribution
• Manage process nonconformances and deviations, including follow-up and liaison with department assignees
• Perform batch record reviews and manage the Quality Notification process
• Support regulatory and customer audits, including inspection preparation and audit responses
• Facilitate rapid containment of product quality issues arising from manufacturing or customer complaints
• Assist with change control, complaint support, and other Quality Assurance initiatives

Requirements

• Associate degree or equivalent in Biology, Chemistry, or a related field
• 4+ years of experience in a regulated industry
• Strong knowledge of GMP and regulatory requirements applicable to US FDA and ISO standards
• Ability to retrieve, organize, and analyze data to reach logical conclusions
• High attention to detail and the ability to multi-task based on shifting priorities
• Self-driven mindset with the ability to prioritize work without micro-management

Preferred Qualifications

• Experience using SAP
• Strong interpersonal skills and ability to work effectively across different departments

Benefits

• Competitive medical plans and free HSA funds
• Paid parental leave and 401k with profit sharing
• Employee stock purchase program
• Mental health platform and wellness support
• Student debt relief program and education benefits
• Paid time off and pet insurance

About the Company

Bio-Rad is a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. For 70 years, we have focused on advancing the discovery process and transforming the fields of science and healthcare to help people live longer, healthier lives.