Sr. Quality Assurance Specialist Job at Danaher Manufacturing, Boulder, CO

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  • Danaher Manufacturing
  • Boulder, CO

Job Description

Integrated DNA Technologies (IDT) is the 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 realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.

IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

This position is part of the Quality Assurance Team located in Boulder, Colorado and will be* on-site *. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things!

In this role, you will have the opportunity to:

  • Maintains records and processes for document handling, audit, process controls (NCR/Deviation/CAPA) and training – may participate in several aspects .

  • Interacts professionally and efficiently with manufacturing and support staff: administer/support the intra-department functionality of the QMS with departments throughout IDT.

  • Prepares reports of quality system performance for internal departmental use, as well as management review.

  • Assists in developing content for and delivering training on various quality systems functions such as NCR’s, deviations, document control, training system administration, and validation activities.

  • Participates in customer and third-party audits, serves as a member of internal audit teams, assists with the development and implementation of responses for customer, regulatory and certifying body audits.

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
  • Experience working in a regulated environment, especially ISO 9001, ISO 13485

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)

You should be proficient in:

  • Quality Inspection Experience
  • ISO 9001 Certification Experience
  • Experience in a Manufacturing Environment

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