Supervisor, IQC

POSITION SUMMARY:

Supervisor, Incoming Quality Control: responsible for the management of the inspection of raw materials, consumables and reagents that require verification of supplier specifications to Natera specifications. This position reports to senior level management in the Natera Reagents Department. Non-technical role.

PRIMARY RESPONSIBILITIES:

• Perform Record Review of Incoming Inspection and Manufacturing

• Provide guidance and Team performance reviews, maintain training records, guide continuous improvement of workflows and maintain workflow and day-to-day schedule

• Perform and prioritize incoming inspection and reagent release as required by incoming workload: Receive, verify, label, and store reagents according to department procedures

• Coordinate intra- and inter-departmentally to support workflows

• Escalation and investigation of Non-Conformities

• Maintain updates and/or create department procedures and forms

• Assists with audits

• Coordinate training/implementation of new process changes

• Optimize IQC workflows by providing and implementing suggestions/ideas for improvement

• Ensure equipment and instruments are in good operating condition

• Verify that data is properly entered into Laboratory Information Management System

• Work cross-functionally with Team and other departments on various platforms

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

• Conduct self in a Professional manner

• Able to perform work with little to no 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:• High School Diploma or GED or equivalent• BS/BA degree (or equivalent) in Biological Sciences, Biology, Chemistry or a related field is preferred• 2+ years of Incoming QC inspection experience or equivalent in a Clinical laboratory environment is preferredKNOWLEDGE, SKILLS, AND ABILITIES:• Computer skills (MS Word, Excel, PowerPoint, etc.) • Good writing and communication skills • Independent worker, a self-starter with strong organizational and planning skills • Basic knowledge of CLIA, FDA, and/or ISO 13485 Good Documentation practicesPHYSICAL DEMANDS & WORK ENVIRONMENT:• Duties typically performed in an office setting • Overtime may be needed to ensure proper storage of temperature sensitive materials • Must be able to sit or stand for long periods of time

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!