Quality Assurance Specialist (Biotech)

TL;DR

Quality Assurance Specialist (Biotech): Oversight and management of quality systems for cell-free DNA testing facility and products with an accent on compliance, safety, and regulatory adherence. Focus on leading change control, trending metrics, handling CAPAs, deviations, complaints, and supporting audits.

US Remote. Must pass post-offer criminal background check and complete HIPAA/PHI training within 30 days.

Company

Global leader in cell-free DNA testing for oncology, women’s health, and organ health.

What you will do

• Oversight and ownership of quality systems including change control leadership.
• Collect and trend quality metrics.
• Lead assistance in CCRS, CAPAs, deviations, SCAR, complaints, and NCRs.
• Review and approve quality records and participate in quality meetings.
• Support documentation and team during audits, schedule quality events.
• Stay current on FDA, ISO13485, CLIA, CAP regulations.

Requirements

• Bachelor’s Degree in Life Sciences, Engineering, Software or equivalent.
• 5+ years working experience in Biotech industry preferred or relevant combination.
• Minimum 3 years knowledge with cord blood, transfusion medicine preferred.
• Experience with biologics, transfusion medicine, tissue/organ, cord blood/stem cells.
• Works with PHI; must complete HIPAA/PHI, compliance, and security training within 30 days.
• Must maintain current hirify.global training and pass criminal background check.

Nice to have

• Prior cryopreservation experience.
• Prior quality or operational experience in medical setting.

Culture & Benefits

• Comprehensive medical, dental, vision, life, disability plans.
• Free testing for employees and families, fertility care benefits.
• Pregnancy and baby bonding leave, 401k, commuter benefits.
• Generous employee referral program.
• Diverse and inclusive workplace.