Quality Assurance Specialist

Natera • Boulder, CO

19h

About The Position

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 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. This role works with Protected Health Information (PHI) on a regular basis, both in paper and electronic form, and has access to various technologies to access PHI to perform the job. The employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training, and security training as soon as possible, but no later than the first 30 days of hire. Must maintain a current status on Natera training requirements. The employee must pass a post-offer criminal background check. Performs other duties as assigned.

Requirements

• 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

Nice To Haves

• 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.

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

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401k benefits.
• Commuter benefits.
• Generous employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees