Quality Assurance (QA) Specialist
Danaher · Boulder, CO
QualityFull-time$63k–$80kCompany career page
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Role summary
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.
What they're looking for
- 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)
What you'll be doing
- 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
Privacy & handoff
This role links to Danaher's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.