Quality Assurance Specialist I-II
$75,000–$85,000 year
Hybrid · Boulder, Colorado, United States
Job Summary
onsite QA Specialist I-II in Boulder, CO supporting ISO 13485-compliant QMS; responsibilities include change control, NC/CAPA investigations, batch record reviews, calibration/validation, document control, internal/external audits, supplier audits, and data analysis; collaborate with production, quality control testing, and cross-site teams; ensure product quality and regulatory compliance; role may include occasional training management and drive for continual improvement; requires a Bachelor’s degree (or equivalent) in molecular biology or related field and 5-7 years of quality experience, with ISO 13485/cGMP experience preferred; base salary $75k-$85k plus bonus and equity; onsite with flexibility to work from home one day a week; local candidates preferred.
Required Qualifications
- Bachelor’s degree (or equivalent) in molecular biology or related field
- 5-7 years quality experience (NC, CAPA, root cause investigations, internal and external audit) with molecular biology product manufacturing, support, and/or product development
Desired Qualifications
- Bachelor's degree in biochemistry, molecular biology, or related discipline
- 5-7 years quality experience in industry
- ISO 13485, ISO 9001, or cGMP experience (preferred)
- experience with NC, CAPA, root cause investigations, internal and external audits
- ability to review and approve quality documents, records, and reports
- calibration and validation experience
- data analysis and continuous improvement
- strong written and verbal communication
- cross-functional teamwork
- ability to work independently across global sites
- detail-oriented and highly organized
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