Serve as consulting resource for receiving inspectionResolve component quality issues using root cause analysis tools, working with suppliers, and performing engineering studies as applicableAddress nonconformances and CAPAs in a compliant and timely manner to meet manufacturing needsCollaborate with supply chain, R&D, manufacturing for supplier/component issues and new components to ensure compliance, feasibility, capability and reproducibility and assess mitigations as neededParticipate in internal & external audits as neededLead process monitoring project to trend supplier performance and track adverse trendsMaintain quality metrics for the site and track project initiatives associated

Develop team members by training new hires on all raw material QC testing and processes following strict GMPConduct routine analysis of raw materials, intermediates and matched kits according to approved SOPs and in compliance with ISO 13485 and Quality System Regulation 21 CFR 820Troubleshoot issues arising during analysis and conduct investigations for any non-conformances or CAPAsImprove and update SOPs as preventative action by using root cause analysis to streamline processes and identify any gaps Provide justification for any deviations from SOP to ensure quality of material Developed systematic approach for prioritizing raw materials to support manufacturing and scheduling needsWork on validation projects to improve assay performance and qualify new vendors or equivalent materialsWork with R&D on product launches involving QC procedures to ensure that the SOP captures essential criteria and executing/updating the SOP as necessary Communicate with manufacturing and planning/scheduling to assist with milestones for product launches, raw material issues and material shortages to ensure on-time deliveryParticipate in Practical Process Improvement projects as part of cross functional team to solve problems and improve turnaround time

- Perform multiple immunoassays on fully automated clinical chemistry analyzers in a cGMP environment such as Hitachi 717, 911 & 917, Olympus AU640 &AU680, Abbott AxSym & c8000, Beckman Synchron & DxC600- Conduct routine analysis of raw materials, intermediates and matched kits according to approved SOPs- Troubleshoot issues arising during analysis and conduct investigations as necessary for any non-conformances or CAPAs- Communicate with R&D, manufacturing and planning/scheduling to assist with milestones for product launches, raw material issues and material shortages to ensure on-time delivery- Develop team members by training new hires on all raw material processes and raw material quality testing

- Processed biohazardous specimens following strict SOPs and GLPs, OSHA and EP regulations- Labeled and verified specimens with test requisition form after data entry- Utilized aseptic and sterile techniques for handling HIV patient blood samples

lab maintenance, making reagents/buffers, PCR, running nucleic acid & protein gels, crystallization, autoclaving, maintained laboratory manual, protein centrifugation, protein expression in E. Coli