Biotech QA Specialist - On-Site Boulder

Danaher Corporation; Boulder (CO); On-site; USD 63,000 - 80,000; Full time

Benefits offered by this job

Bonus eligible

Comprehensive benefits

Job summary

Integrated DNA Technologies (IDT) in Boulder, CO, seeks a Quality Assurance Specialist to administer and maintain the QMS, handle document control, deviations, and training, and support batch release activities on-site. The role requires a life sciences degree and QA experience in biotechnology.

The position reports to the QA Manager and offers bonus eligibility plus a comprehensive benefits package. Familiarity with SAP, MasterControl, and Maintenance Connection is a plus.

Qualifications

• Bachelor’s degree in life sciences (biology, chemistry, biochemistry, et cor related field).
• 1+ years of Quality Assurance experience in the manufacturing industry, especially in biotechnology and next-generation sequencing.
• Experience with ISO:9000/ISO:13485 and FDA QSR/cGMP standards.
• Proficiency with computers and Microsoft Office Suite.

Responsibilities

• Perform timely review and release of batch records, DHRs, and inspection results to ensure compliance with product specifications and procedures.
• Maintain and support document control and training processes within the eQMS, including reviews and approvals and record retention.
• Initiate, investigate, and support closure of quality events (Nonconformances, Deviations, CAPAs) using root cause analysis.
• Collaborate with Manufacturing, Logistics, Quality Control, and Supply Chain Planning to ensure compliance and continuous improvement.
• Participate in internal and external audits as needed.

Skills

Quality Assurance

Documentation

Computer proficiency

Education

Bachelor’s degree in life sciences

Tools

SAP

MasterControl

Maintenance Connection

Job description

Integrated DNA Technologies (IDT) in Boulder, CO, seeks a Quality Assurance Specialist to administer and maintain the QMS, handle document control, deviations, and training, and support batch release activities on-site. The role requires a life sciences degree and QA experience in biotechnology.

The position reports to the QA Manager and offers bonus eligibility plus a comprehensive benefits package. Familiarity with SAP, MasterControl, and Maintenance Connection is a plus.