The QC Specialist works both independently and as part of a team to complete required screening of raw materials and both in-process and finished product QC testing for the manufacture and release of Bio-Rad infectious disease quality controls. Perfoms initial investigations, corrective actions, and risk assessments for disposition of nonconforming materials and products.
- Perform required QC testing and inspection of raw materials, chemical components, in-process and finished products.
- Compile and review QC testing data in compliance with quality system procedures and on time to meet manufacturing schedules and avoid product backorders.
- Perform intitial and root cause investigations, corrective action assesments, and risk assessments for disposition of nonconforming materials and products.
- Prepare technical documentation of high risk products for submission to and review by Notified Body prior to release of products for sale.
- Operate and troubleshoot QC testing instruments; ensure that all equipment is calibrated and maintained as required per defined schedules.
- Maintain QC testing database and analyze stability trends to ensure products meet performance claims; collaborate with manufacturing and R&D group on the resolution of quality issues.
- Monitor and replenish test kits, reagents, and supplies to ensure sufficient inventory is on-hand to meet testing schedules.
- Provides technical guidance and support for less experienced team members.
- Writes standard operating procedures (SOPs) and delivers presentations.
Bachelor's degree, or equivalent, in a life science or related field
5+ years of experience in a clinical laboratory environment, or equivalent combination of education and experience
Expertise in the use of clinical laboratory techniques and equipment
Expertise in instrument operation, calibration, and troubleshooting
Experience working in a Good Manufacturing Practice/Good Laboratory Practice (GMP/GLP) environment
Experience with immunoassay and/or chemistry testing platforms preferred
Experience with SAP or other ERP systems preferred