Iqc-Rgt Associate 1

POSITION SUMMARY:

Support the activities for reagents used in the Operations Department's Clinical Laboratories, which includes but is not limited to incoming material inspections to assure product safety and compliance to specifications, GMP's, and ISO requirements

PRIMARY RESPONSIBILITIES:

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

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

• Responsible for ensuring reagents are stored in appropriate conditions

• Ensures all dispenses are qualified and accounted for

• Verify that data is properly entered into laboratory inventory system

• Stock laboratory with qualified reagents and consumables

• Performs routine incoming inspection and documentation for product release

• Able to perform work with little to no supervision.

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

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

• Assists teammates in completing daily tasks

• Ensures work is completed in a timely manner

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

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

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

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

• Reports Non-Conformity of SOPs to supervisor/manager

• Submit Non-Conformance Report (NCR) when applicable

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

• Maintains clean and organized workspace

• Dispose of waste in compliance with Safety & Environmental procedures

• Keeps team morale up and maintains professionalism of team members

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

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

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

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

• Provides guidance and constructive feedback to team members

• Meet expected performance metrics within role

• Assist in training/implementation of new process changes

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

• Assist in training new hires

• Assist with internal audits and inspection preparation

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

• Assist with reagent preparation and qualifications as needed

• Assist with internal audits and inspection preparation as needed

• Compile data and prepares reports as needed

• Participate in Continuous Improvement Projects as needed

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:

• High School Diploma or GED or equivalent

• 1+ years of QC experience or equivalent in a clinical laboratory environment is preferred

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

• Relevant Molecular Biology experience in a laboratory setting 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 fast-paced team environment

• Ability to promote a positive team environment

• Adaptability and Flexibility 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

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

San Carlos, CA

$1-$1 USD

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