Supervisor 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.

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.

Qualifications

, Maintenance Log, etc Responsible for day-to-day operational staffing, including hiring/training of personnel. Administer company policies and management guidance that directly affect employees. Meet regularly with individual contributors to discuss goals and performance.

Keep team morale up and maintains professionalism of team members. Able to take on own projects with little supervision. Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R D, Support and Product Development.

5+ years of experience if BS/BA degree (or equivalent) in Biological Sciences or related field is required Relevant Molecular Biology and/or Cell Culture experience in a laboratory setting is strongly preferred Experience with writing of SOP’s and QC documentation is preferred For California site Current California State CLS or CGMBS license (Clinical Genetics Molecular Biologist Scientist) is required For Texas site Current MT/MTS/CLS certification from ASCP, AMT, or AAB is required KNOWLEDGE, SKILLS AND ABILITIES Strong leadership skills Normally receives no instruction on routine work, general instructions on new projects or assignments Strong interpersonal, communication, computer, troubleshooting, and pipetting skills. Strong oral and written communication skills. Word processing and data management skills.

Experience in PCR and other Molecular Biology Techniques. Understanding of Quality Control methods development and implementation. Supply chain, document control, and regulatory compliance experience.

Requirements