Sr Quality Assurance (QA) Specialist

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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 youll be part of a culture rooted in continuous learning and improvementwhere 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 IDTs Quality Management System in accordance with ISOCFR 820 and regulatory guidance documents. Works with the IDT Global QS team.
• Participate in internal and external audits as needed.

The essential requirements of the job include:

• Bachelors 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.

It would be a plus if you also possess previous experience in:

• 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

IDT a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is $85000 - $100000. 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 comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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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.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .