Quality Assurance Specialist

2 days ago


Boulder, Colorado, United States Danaher Corporation Full time
Quality Assurance Specialist

Integrated DNA Technologies (IDT) is a leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.

About the Role

This position is part of the Quality Assurance Team located in Boulder, Colorado and will be on-site. As a Quality Assurance Specialist, you will have the opportunity to:

  • Maintain records and processes for document handling, audit, process controls (NCR/Deviation/CAPA) and training.
  • Interact professionally and efficiently with manufacturing and support staff to administer/support the intra-department functionality of the QMS.
  • Prepare reports of quality system performance for internal departmental use, as well as management review.
  • Assist in developing content for and delivering training on various quality systems functions.
  • Participate in customer and third-party audits, serve as a member of internal audit teams, and assist with the development and implementation of responses for customer, regulatory and certifying body audits.
Requirements

The essential requirements of the job include:

  • Bachelor's degree in life sciences (biology, chemistry, biochemistry, etc.) or related field or Advanced degree (Master's or PhD) in life science.
  • 3+ years of experience in a manufacturing environment, especially life science or biotechnology industries.
  • 3+ years of experience in a manufacturing operations, quality control, or quality assurance role.
  • Demonstrated technical ability and accuracy to perform mathematical calculations and unit conversions.
  • Demonstrated ability to adhere to strictly defined protocols and procedures.
Preferred Qualifications

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

  • Familiarity with SAP, MasterControl, and Maintenance Connection.
  • Experience working in a regulated laboratory environment in the biotech industry or academic environment.
  • Quality Assurance experience in the manufacturing industry, especially biotechnology and next-generation sequencing (NGS).
  • Experience working in a regulated environment, especially ISO 9001, ISO 13485.
What We Offer

This job is eligible for bonus/incentive pay. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

At Danaher Corporation, we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's 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.

We are an equal opportunity employer and value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.



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