Biotech QA Specialist: Drive Quality & Compliance

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

Benefits offered by this job

Bonus potential

Medical/dental/vision insurance

Retirement benefits

Paid time off

Job summary

Integrated DNA Technologies (IDT) in Boulder, CO seeks a QA Specialist to administer the quality management system and coordinate batch record reviews, deviations, and CAPAs. You will support training, audits, and cross-functional quality initiatives on-site.

Qualified candidates have a life sciences degree and 1+ year QA experience in biotech, with ISO 9000/13485 and FDA QSR/cGMP familiarity; SAP/MasterControl experience is a plus. Competitive benefits and bonus eligible.

Qualifications

• Bachelor’s degree in life sciences or related field required.
• 1+ year QA experience in biotech/manufacturing environment.
• Familiar with ISO 9000/13485 and FDA QSR/cGMP standards.
• Proficient with Microsoft Office tools.
• Experience with SAP, MasterControl or Maintenance Connection is a plus.

Responsibilities

• Review and release batch records, DHRs, and test results to ensure compliance.
• Maintain document control and training within the eQMS system.
• Initiate and investigate quality events, root cause analysis, and CAPAs.
• Collaborate with Manufacturing, Logistics, QC, and Supply Chain teams.
• Participate in internal and external QA audits.

Skills

Batch records review

DHR review

QMS administration

Deviations & CAPAs

Audits

ISO 9000/13485 & FDA QSR/cGMP

Microsoft Office

Education

Bachelor’s degree in life sciences

Tools

SAP

MasterControl

Maintenance Connection

Job description

Integrated DNA Technologies (IDT) in Boulder, CO seeks a QA Specialist to administer the quality management system and coordinate batch record reviews, deviations, and CAPAs. You will support training, audits, and cross-functional quality initiatives on-site.

Qualified candidates have a life sciences degree and 1+ year QA experience in biotech, with ISO 9000/13485 and FDA QSR/cGMP familiarity; SAP/MasterControl experience is a plus. Competitive benefits and bonus eligible.