QC Reagent Associate

POSITION SUMMARY:

Executes the preparation and qualification of molecular diagnostic reagents.

 

PRIMARY RESPONSIBILITIES:

• Perform routine Quality Control tests on new incoming shipments of raw materials and small-scale manufacturing procedures (formulations and dispensing) reagents following the standard methods and procedures typically under supervision

• Reviews data obtained for compliance to specifications and reports abnormalities/discrepancies

• Receive, verify, label, store reagents according to department procedures

• Coordinate labeling and dispensing for reagents following standard operating procedures with little to no errors

• Stock laboratory with qualified reagents and consumables as needed

• Assist with reagent preparation and qualifications

• Verify that data is properly entered into laboratory inventory system

• Maintain and update QC Records, QC documentation (raw material specification, reagent qualification, and QC testing), Cleaning and Maintenance Records

• Document all corrective actions taken when test systems deviate from the established performance specifications as needed

• Meet expected performance metrics within role as applicable

• Follows/Ensures GLP (good laboratory practices) and GMP (good manufacturing practices) compliance

• Reports Non-Conformity of SOPs to lead/supervisor/manager

• Submit Non-Conformance Report (NCR) when applicable

• Ensures work is consistently completed in a timely manner

• Ensures all dispenses are qualified and accounted for

• Assists in training new hires

• Assists in training/implementation of new process changes, as needed

• Recognizes, escalates, and troubleshoot equipment malfunctions and most processing errors according to the laboratory’s standard operating procedures

• Maintains equipment and instruments in good operating condition (such as calibration and expiration date)

• Recognizes, documents, and escalates protocol deviations in lab to lead/supervisor/manager

• Communicates with team and other departments on various platforms (including via e-mail)

• Provides feedback on day-to-day schedule and tasks to lead/supervisor/manager

• Assists teammates in completing daily tasks

• Assists in planning workflow and day-to-day schedule

• Works intra and inter departmentally to provide support and solutions for workflow.

• Perform materials, supplies, and equipment tracking and planning in the laboratory for performance of duties

• Work cross-functionally with other departments to ensure timelines are met

• Dispose of waste in compliance with Safety & Environmental procedures

• Able to perform work with minimal supervision

• Participate in Continuous Improvement Projects

• Escalates issues/team concerns and suggests possible solutions to lead/supervisor/manager

• Assist with internal audits and inspection preparation, as needed

• Provides guidance and constructive feedback to team members

• Offers suggestions/ideas for improvement and assists with developing team’s troubleshooting and judgement skills

• Keeps team morale up and maintains professionalism of team members• Maintains clean and organized workspace

• Conducts himself/herself in a professional manner

• Adheres 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

•  Performs other duties as assigned

 

QUALIFICATIONS:

• 1+ year of relevant Molecular Biology experience in a laboratory setting is preferred

• BS/BA degree (or equivalent) in Biological Sciences, Biology, Chemistry, or related field

• QC and/or development background is preferred

• Experience with writing of SOP’s and QC documentation is preferred

 

KNOWLEDGE, SKILLS, AND ABILITIES:

• Able to multi-task and work independently in a team environment

• Ability to promote a positive team environment

• Adaptability in a frequently changing environment

• Maintain a high level of professionalism and responsibility

• Excellent interpersonal, communication, computer (MS word, Excel, PowerPoint, etc.), troubleshooting, organizational, problem-solving, and technical skills

• Excellent oral and written communication skills

• Basic knowledge in Data management, Google Docs, LIMS, and Continuous Improvement

• Takes initiative and ownership of projects/assignments with attention to detail

• Accepts and incorporates feedback

• Willingness to learn

• Actively seeks ways to improve quality and workflows

• Strong time management skills

• Punctual and consistent attendance

• Ability to speak, read, and write in English

 

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