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Quality Assurance Specialist

2 months ago


Boulder, Colorado, United States Danaher Corporation Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Danaher Corporation. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services, and contributing to the success of our organization.

Key Responsibilities
  • Maintain accurate and detailed records of quality system performance, including audit reports and process controls.
  • Collaborate with manufacturing and support staff to ensure efficient and effective quality management systems.
  • Prepare and present quality system performance reports to internal stakeholders and management.
  • Develop and deliver training programs on quality systems functions, including NCRs, deviations, document control, and validation activities.
  • Participate in customer and third-party audits, and assist with the development and implementation of responses to audit findings.
Requirements
  • Bachelor's degree in life sciences or related field, or advanced degree in life science.
  • 3+ years of experience in a manufacturing environment, particularly in 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
  • 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, particularly in biotechnology and next-generation sequencing (NGS).
  • Experience working in a regulated environment, particularly ISO 9001, ISO 13485.
What We Offer
  • Competitive salary range: $72,000 - $90,000.
  • Bonus/incentive pay eligible.
  • Comprehensive benefits package, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.