Quality Assurance (QA) Specialist

Quality Assurance SpecialistAre you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Integrated DNA Technologies (IDT), one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact.You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.Our team at Integrated DNA Technologies (IDT), is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more. At IDT, you'll be part of a culture rooted in continuous learning and improvement—where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all.Learn about the Danaher Business System which makes everything possible.The Quality Assurance (QA) Specialist is responsible for providing administration, coordination, and maintaining the key components of the Quality Management System (QMS) at the Boulder, CO site. This may include but is not limited to document control, nonconformances, deviations, training, batch record review and release, and other process control functions.This position reports to the Manager of Quality Assurance and is part of the Quality Assurance team located in Boulder, CO and will be an on-site role.In this role, you will have the opportunity to:Perform timely review and release of batch records, Device History Records (DHRs), and inspection results for raw materials, in-process materials, subassemblies, and finished goods to ensure compliance with product specifications, quality requirements, and procedures.Maintain and support document control and training processes within the eQMS, including document control review and approvals, employee training assignments, and physical record retention.Initiate, investigate, and support closure of quality events, including Nonconformances, Deviations, CAPAs, and Issue Reviews, utilizing risk-based and root cause analysis methodologies.Collaborate effectively with Manufacturing, Logistics, Quality Control, Supply Chain Planning, and other cross-functional teams to ensure compliance with quality system requirements and support continuous improvement initiatives.Participate and represent the Quality organization in internal and external audits, as needed.The essential requirements of the job include:Bachelor's degree in life sciences (biology, chemistry, biochemistry, etc or related field)1+ years of Quality Assurance experience in the manufacturing industry, especially in biotechnology and next-generation sequencingExperience and familiarity working with ISO:9000/ISO:13485 standards and FDA QSR/cGMP standards.Proficiency with computers and a variety of software, especially Microsoft Office Suite.It would be a plus if you also possess previous experience in:SAP, MasterControl, and/or Maintenance Connection systemsThe annual salary range for this role is between $63,000.00 - 80,000.00 USD Annual. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and Retirement Benefits to eligible employees.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.