Sr Quality Assurance (QA) Specialist

Danaher-posted 4 months ago
$85,000 - $100,000/Yr
Full-time • Mid Level
Boulder, CO
Computer and Electronic Product Manufacturing
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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. Our team at IDT is committed to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. 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 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.

  • 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.
  • Participate in internal and external audits, as needed.
  • 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.
  • Proficiency with computers and a variety of software i.e. Microsoft Office Suite, etc.
  • 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.
  • Experience with SAP, MasterControl, and Maintenance Connection.
  • Comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
  • Bonus/incentive pay.
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