Sr Quality Assurance (QA) Specialist

Danaher•Boulder, CO

4d•$85,000 - $100,000•Onsite

About The Position

Bring more to life. Are 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 Sr Quality Assurance (QA) Specialist is responsible for providing administration, coordination, and maintaining the key components of the Quality Management System at the Boulder, CO site. This may include but is not limited to document control, nonconformances, deviations, training and other process control functions. This position reports to the Sr Manager, Quality Systems and is part of the Quality and Regulatory Affairs group located in Boulder Colorado and will be an on-site role. In this role, you will have the opportunity to: Ensure the timely completion and investigation into Quality event investigations (Nonconformances, Deviations, and support of Customer Complaints). Complete timely review and release of batch records, inspections, and COA creation for various raw materials, in-process materials, subassemblies, and finished goods in accordance with product specifications. Interact professionally and efficiently cross functionally with Manufacturing and various support teams; Logistics, R D, Product Management, Supply Chain Planning, and QC. Implement, maintain, and improve IDT's Quality Management System in accordance with ISO 13485, 21 CFR 820 and regulatory guidance documents. Works with the IDT Global QS team. Participate in internal and external audits, as needed.

Requirements

Bachelor's degree in life sciences preferably in one of the following biology, chemistry, biochemistry or related field
3+ years of Quality Assurance experience in a manufacturing industry, biotechnology and next-generation sequencing preferred
3+ years of experience working in medical devices preferred
Experience with quality management systems and regulatory standards such as ISO:9000, ISO:13485. FDA QSR, or cGMP is preferred. Candidates should be able to demonstrate familiarity with one or more of these frameworks through prior experience in a regulated environment.
Proficiency with computers and a variety of software i.e. Microsoft Office Suite, etc.

Nice To Haves

Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management.
Ability to accept responsibility for the direction, control or planning of a project.
SAP, MasterControl, and Maintenance Connection

Responsibilities

Ensure the timely completion and investigation into Quality event investigations (Nonconformances, Deviations, and support of Customer Complaints).
Complete timely review and release of batch records, inspections, and COA creation for various raw materials, in-process materials, subassemblies, and finished goods in accordance with product specifications.
Interact professionally and efficiently cross functionally with Manufacturing and various support teams; Logistics, R D, Product Management, Supply Chain Planning, and QC.
Implement, maintain, and improve IDT's Quality Management System in accordance with ISO 13485, 21 CFR 820 and regulatory guidance documents.
Works with the IDT Global QS team.
Participate in internal and external audits, as needed.

Benefits

IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
Whether it's a health care program or paid time off, our programs contribute to life beyond the job.
Check out our benefits at Danaher Benefits Info.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

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