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About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
- 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.
Benefits
Comp & perks- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Free testing for Natera employees and their immediate families in addition to fertility care benefits.
- Pregnancy and baby bonding leave.
- 401k benefits.
- Commuter benefits.
- Employee referral program.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality System OversightChange ControlQuality Metrics CollectionCCRSCAPAsDeviationsSCARComplaintsNCRsCryopreservation
Soft Skills
LeadershipCollaborationCommunicationOrganizational SkillsAttention to Detail
Certifications
Bachelor’s Degree in Life SciencesBachelor’s Degree in EngineeringBachelor’s Degree in Software