Quality Assurance Specialist

Quality Assurance Specialist

Boulder, CO

The Quality Assurance Specialist participates in the day to day management and operations of the facility, products and vendors. Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Quality Specialist 3 ensures safety, quality and compliance with all relevant procedures, state and federal regulations and customer expectations. Ensures smooth and safe operations of the storage facility through stakeholder and vendor engagement.

PRIMARY RESPONSIBILITIES:

• Oversight and Ownership of a Quality System (e.g. Change Control Lead including system and board lead)
• Collecting and trending quality metrics
• Assistance and leadership in CCRS, CAPAs, Deviations, SCAR, Complaints, and NCRs and filing completed records.
• Partner to provide review and approval of Quality Records
• Participate and contribute in Quality related meetings
• Assist with obtaining documentation and supporting the team during audits
• Work to help schedule Quality Events and Meetings
• Stays current on applicable regulation and guidance from FDA, ISO13485, CLIA, CAP, etc
• This role works with PHI on a regular basis both in paper and electronic form and has 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.
• Performs other duties as assigned

QUALIFICATIONS:

• Bachelor's Degree in Life Sciences, Engineering, Software or equivalent
• 5+ year of working experience in Biotech industry preferred Or a relevant combination of skills, education, and experience

KNOWLEDGE, SKILLS, AND ABILITIES:

• Minimum of 3 years of knowledge with cord blood, transfusion medicine preferred.
• Experience with biologics, transfusion medicine, tissue/organ or cord blood/stem cells or equivalent.
• Prior cryopreservation experience is a plus.
• Prior quality or operational experience in a medical setting is a plus.

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!