other
Posted 1 hour agoSupervisor QC Reagent
at Natera
San Carlos, United StatesOn-site
Responsibilities
- Ensure quality work is completed timely. PRIMARY RESPONSIBILITIES
- 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 •
- 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. •
- Lead Continuous Improvement Projects •
- Perform Record Review of Incoming Inspection, Manufacturing, Qualifications, Maintenance Log, etc •
- Administer company policies and management guidance that directly affect employees. •
- Follow/Ensure GLP (good laboratory practices) and GMP (good manufacturing practices) compliance •
- Conduct self in a Professional manner •
- Perform other duties as assigned •
Requirements
- Must maintain a current status on Natera training requirements
- 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
- 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
- Experience in PCR and other Molecular Biology Techniques.
- Understanding of Quality Control methods development and implementation.
- Experience in a regulated environment, GMP, ISO, CLIA, CAP, and Aseptic techniques PHYSICAL DEMANDS & WORK ENVIRONMENT
- Must be able to lift up to 50lbs and perform laborious tasks
- This position requires the ability to use a computer keyboard, handheld scanning device, communicate via electronics, read materials, and use equipment in reagent preparation
- Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.
Experience
- QUALIFICATIONS 4+ years of
Benefits
- 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.
- This position is also eligible for additional compensation and
- benefits through Natera’s robust Total Rewards program, including: •
- Annual performance incentive bonus •
- Long-term equity awards •
- Comprehensive health benefits (medical, dental, vision) •
- Generous paid time off and company holidays •
- Compensation Range $83,400 — $122,550 USD OUR OPPORTUNITY
- 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.
- benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other
- benefits include pregnancy and baby bonding leave, 401k benefits, commuter
Contact
- For more information, visit www.natera.com .
- Link: https://www.natera.com/notice-of-data-collection-california-residents/
- Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY.
Additional details
- POSITION SUMMARY The Supervisor, QC Reagent will manage day-to-day operations of manufacturing and testing of consumable reagents to support production.
- 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. •
- Escalate issues/concerns and suggests possible solutions and collaborates with Manager to resolve issues •
- Knowledgeable & competent in Reagent Team Benchwork & Data Analysis •
- 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. •
- 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 •
- Responsible for day-to-day operational staffing, including hiring/training of personnel. •
- Meet regularly with individual contributors to discuss goals and performance. •