Supv, QC Reagent

POSITION SUMMARY

The Supervisor, QC Reagent will manage day-to-day operations of manufacturing and testing of consumable reagents to support production. Works closely with Manager to ensure company and Team goals are met. Ensure quality work is completed timely.

PRIMARY RESPONSIBILITIES

• Provide direct supervision and follow up to individual contributors in a highly regulated environment (CLIA/CAP/ISO13485) to ensure adherence to SOPs and safety procedures. 

• Perform, troubleshoot and follow up incoming inspection, manufacturing and Quality Control tests for reagent release: 

• Support and leads development of workflow troubleshooting and procedure improvements 

• Escalate issues/concerns and suggests possible solutions and collaborates with Manager to resolve issues 

• Knowledgeable & competent in Reagent Team Benchwork & Data Analysis 

• Support and provide approvals for QC documentation updates 

• Oversee and maintain training records for new hires 

• Implement new process changes, tech transfers, planning workflow and reagent preparation and qualification. 

• Provide direction and guidance to employees 

• Provide direction for planning meetings to meet Turnaround time (TAT) to ensure work is 

consistently completed according to department goals. 

• Assist with Audit preparation by compiling data and prepares reports as needed. 

Lead Continuous Improvement Projects 

• Participate in the preparation of investigations, summaries, and reports 

• Assist in maintaining, updating, and approving documents pertaining to raw material 

specifications, reagent qualification