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, 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 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. 

• Follow/Ensure GLP (good laboratory practices) and GMP (good manufacturing practices) compliance 

Conduct self in a Professional manner 

• Perform other duties as assigned

Adhere to Departmental Expectations 

• This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job 

• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire 

• Must maintain a 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 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 & ABILITILIES

 

• 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 50lbs 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 

• This position requires the 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 (ie. BSL-1, BSL-2, etc.) with potentially hazardous material and in an office setting 

• Duties require wearing safety goggles, gloves, and lab coat 

• Duties may require working outside shift working hours, evenings, weekends, holidays, and/or overtime 

 

Travel required for this position: 

Noor Yes: If yes state anticipated percent for travel:

 

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.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee 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 benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

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.

If you are based in California, we encourage you to read this important information for California residents. 

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. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:
- BBB announcement on job scams 
- FBI Cyber Crime resource page