Quality Assurance (QA) Specialist (Biotechnology)

Location: On-site in Boulder, Colorado, United States

Salary: $63,000–$80,000 annual, plus eligibility for bonus or incentive pay

Company

hirify.global operates Integrated DNA Technologies, a biotechnology and genomics organization focused on supporting research and advances in cancer, infectious disease, and rare genetic disorders.

What you will do

• Review and release batch records, Device History Records, inspection results, and materials documentation.
• Maintain document control, employee training assignments, and physical record retention within the electronic quality management system.
• Initiate, investigate, and support closure of nonconformances, deviations, CAPAs, and issue reviews.
• Apply risk-based and root cause analysis methodologies to quality events.
• Collaborate with Manufacturing, Logistics, Quality Control, Supply Chain Planning, and other cross-functional teams.
• Represent Quality Assurance in internal and external audits and support continuous improvement initiatives.

Requirements

• Bachelor’s degree in life sciences such as biology, chemistry, biochemistry, or a related field.
• At least 1 year of Quality Assurance experience in manufacturing, preferably in biotechnology or next-generation sequencing.
• Familiarity with ISO 9000, ISO 13485, FDA QSR, and cGMP standards.
• Proficiency with computers and Microsoft Office Suite.
• Availability to work on-site in Boulder, Colorado.

Nice to have

• Experience with SAP, MasterControl, or Maintenance Connection.

Culture & Benefits

• Culture focused on collaboration, scientific excellence, continuous learning, and continuous improvement.
• Paid time off.
• Medical, dental, and vision insurance for eligible employees.
• Retirement benefits for eligible employees.
• Bonus or incentive pay eligibility.