Quality Assurance (QA) Specialist
Danaher Corporation
Summary
The Quality Assurance (QA) Specialist is responsible for providing administration, coordination, and maintaining the key components of the Quality Management System (QMS) at the Boulder, CO site. This may include but is not limited to document control, nonconformances, deviations, training, batch record review and release, and other process control functions. This position reports to the Manager of Quality Assurance and is part of the Quality Assurance team located in Boulder, CO and will be an on-site role.
Job description
In this role, you will have the opportunity to:
- Perform timely review and release of batch records, Device History Records (DHRs), and inspection results for raw materials, in-process materials, subassemblies, and finished goods to ensure compliance with product specifications, quality requirements, and procedures.
- Maintain and support document control and training processes within the eQMS, including document control review and approvals, employee training assignments, and physical record retention.
- Initiate, investigate, and support closure of quality events, including Nonconformances, Deviations, CAPAs, and Issue Reviews, utilizing risk-based and root cause analysis methodologies.
- Collaborate effectively with Manufacturing, Logistics, Quality Control, Supply Chain Planning, and other cross-functional teams to ensure compliance with quality system requirements and support continuous improvement initiatives.
- Participate and represent the Quality organization in internal and external audits, as needed.
The essential requirements of the job include:
- Bachelor’s degree in life sciences (biology, chemistry, biochemistry, etc or related field)
- 1+ years of Quality Assurance experience in the manufacturing industry, especially in biotechnology and next-generation sequencing
- Experience and familiarity working with ISO:9000/ISO:13485 standards and FDA QSR/cGMP standards.
- Proficiency with computers and a variety of software, especially Microsoft Office Suite
It would be a plus if you also possess previous experience in:
SAP, MasterControl, and/or Maintenance Connection systems
Requirements
- Bachelor’s degree in life sciences (biology, chemistry, biochemistry, etc or related field)
- 1+ years of Quality Assurance experience in the manufacturing industry, especially in biotechnology and next-generation sequencing
- Experience and familiarity working with ISO:9000/ISO:13485 standards and FDA QSR/cGMP standards
- Proficiency with computers and a variety of software, especially Microsoft Office Suite
- SAP, MasterControl, and/or Maintenance Connection systems
Benefits
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- Retirement benefits
- Bonus/incentive pay
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.