Biotech QA Specialist - Impactful Quality & Compliance

Integrated DNA Technologies

Boulder (CO)

On-site

USD 63,000 - 80,000

Full time

2 days ago

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Benefits offered by this job

Paid time off

Medical/dental/vision insurance

Retirement benefits

Job summary

Integrated DNA Technologies (IDT) seeks a Quality Assurance Specialist for its Boulder, CO site. The role administers and coordinates the QMS, handling document control, nonconformances, deviations, training, batch records review and release, and other process-control tasks in an on-site capacity.

You will work with Manufacturing, Logistics, QC and Supply Chain to ensure quality system compliance, while audits are supported as needed.

Qualifications

Bachelor's degree in life sciences (biology, chemistry, biochemistry, or related field).
1+ years of Quality Assurance experience in manufacturing, biotechnology or next-generation sequencing.
Experience with ISO 9000/13485 and FDA QSR/cGMP standards.
Proficiency with computers and a variety of software, especially Microsoft Office Suites.

Responsibilities

Review and release batch records, Device History Records (DHRs), and inspection results to ensure conformance to specifications and procedures.
Maintain and support document control and training processes within the eQMS, including review/approvals and record retention.
Initiate, investigate, and support closure of quality events, including nonconformances, deviations, CAPAs, and issue investigations.
Collaborate with Manufacturing, Logistics, Quality Control, Supply Chain Planning, and other cross-functional teams to ensure compliance with quality system requirements.
Participate in internal and external audits as needed.