Supervisor QC Reagent
$105.4k - $131.75kNatera
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 lead development of workflow troubleshooting and procedure improvements. Escalate issues/concerns and suggest possible solutions and collaborate with Manager to resolve issues. 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 preparing reports as needed. Participate in the preparation of investigations, summaries, and reports. Assist in maintaining, updating, and approving documents pertaining to raw material specifications, reagent qualification, laboratory procedures, and department training. Perform record review of incoming inspection, manufacturing, 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 maintain professionalism of team members. Able to take on own projects with little supervision. Actively interact with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, Support and Product Development. Follow/ensure GLP and GMP compliance. Conduct self in a professional manner. Perform other duties as assigned. Adhere to departmental expectations. Work with PHI regularly both in paper and electronic form; complete required HIPAA/PHI privacy training within 30 days of hire; maintain current status on Natera training requirements.QUALIFICATIONS
4+ years of experience if degree is in CLS/MLS or 4.5+ 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 SOPs and QC documentation is preferred. 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. Experience in a regulated environment, GMP, ISO, CLIA, CAP, and aseptic techniques.PHYSICAL DEMANDS & WORK ENVIRONMENT
Must be able to lift up to 50 lbs and perform laborious tasks. Standing or sitting for long periods of time may be necessary. Duties require exposure to cold air due to frequent accessing of refrigeration/freezer units. Position requires ability to use a computer keyboard, handheld scanning device, communicate via electronics, read materials, and use equipment in reagent preparation. Duties are performed in a laboratory setting (e.g., BSL-1, BSL-2, etc.) with potentially hazardous material and in an office setting. Duties require wearing safety goggles, gloves, and lab coat.COMPENSATION & TOTAL REWARDS
This range reflects a good‑faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations. Compensation range: $105,400 - $131,750 USD. Benefits include: Annual performance incentive bonus. Long‑term equity awards. 401(k) with company match. Generous paid time off and company holidays. Additional wellness and work‑life benefits.OUR OPPORTUNITY
Natera™ is a global leader in cell‑free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.WHAT WE OFFER
Competitive benefits: comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.EEO STATEMENT
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. #J-18808-Ljbffr NateraVacancy posted 1 day ago
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