Quality Assurance (QA) Specialist

Quality Assurance Specialist at Integrated DNA Technologies (Danaher) in Boulder, Colorado, responsible for administering and coordinating the Quality Management System. The role includes batch record review, document control, quality event investigation, and cross-functional collaboration to ensure regulatory compliance.

Responsibilities

• Review and release batch records, Device History Records, and inspection results for materials and finished goods
• Maintain document control and training processes within the electronic Quality Management System
• Initiate, investigate, and support closure of nonconformances, deviations, CAPAs, and quality events
• Collaborate with Manufacturing, Logistics, Quality Control, and Supply Chain teams on compliance and improvement initiatives
• Participate in internal and external audits representing the Quality organization

Requirements

• Bachelor's degree in life sciences, chemistry, biochemistry, or related field
• 1+ years Quality Assurance experience in manufacturing, preferably biotechnology or next-generation sequencing
• Knowledge of ISO 9000/ISO 13485 standards and FDA QSR/cGMP regulations
• Proficiency with Microsoft Office Suite and computer software
• Experience with SAP, MasterControl, or Maintenance Connection systems (preferred)

Compensation: $63,000–$80,000 base, plus eligible bonus/incentive pay