QC Reagent Assoc 1

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required.

POSITION SUMMARY:

Support the activities for reagents used in the Operations Department’s Clinical Laboratories. Executes the preparation and qualification of molecular diagnostic reagents. Performs Quality Control tests on new incoming shipments of raw materials and small-scale manufacturing procedures (formulations and dispensing) reagent. Reviews data obtained for compliance to specifications and reports abnormalities. Maintains and improves QC documentation pertaining to raw material specification, reagent qualification, and QC testing. Support Incoming Quality Control activities as needed.

PRIMARY RESPONSIBILITIES:

• Maintain cell lines needed for reagent production and testing. Ensure that cultures remain uncontaminated, properly curated, and maintained according to best practices. • Maintain and improve documentation pertaining to raw material specifications, cell line maintenance, reagent qualification, and QC testing.

• Perform incoming inspection and reagent release: Receive, verify, label, store reagents according to department procedures
• Coordinate labeling and prep for reagents following standard operating procedures
• Perform routine Quality Control tests on new incoming shipments of raw materials and manufacturing procedures (formulations and dispensing) reagents following the standard methods and procedures
• Recognize and escalate equipment malfunctions/processing errors according to the laboratory’s standard operating procedures
• Optimize QC workflows by providing suggestions/ideas for improvement
• Escalate issues/concerns and suggest possible solutions
• Support QC documentation updates
• Work intra- and inter-departmentally to support workflows
• Work cross-functionally with Team and other departments on various platforms
• Follow/Ensure GLP (good laboratory practices) and GMP (good manufacturing practices) compliance
• Escalates Non-Conformity
• Conduct self in a professional manner
• Able to perform work with minimal supervision
• 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
• Employee must pass post offer criminal background check

QUALIFICATIONS:

• BS/BA degree (or equivalent) in Biological Sciences, Biology, Chemistry or a related field
• 1+ years of QC experience or equivalent in a Clinical laboratory environment is preferred
• Relevant Molecular Biology and/or Cell Culture experience in a laboratory setting is strongly preferred

KNOWLEDGE, SKILLS, AND ABILITIES:

• Adaptability and Flexibility in a frequently changing environment
• Able to multi-task and work independently in a fast-paced Team environment
• Excellent interpersonal, communication, computer (MS word, Excel, PowerPoint, etc.), troubleshooting, organizational, problem-solving, and technical skills
• Strong time management skills
• Actively seeks ways to improve quality and workflows
• Willingness to learn
• Ability to promote a positive Team environment
• Maintain a high level of professionalism and responsibility
• 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
• 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.

WHA