Quality Assurance (QA) Specialist

Danaher Corporation; Boulder (CO); On-site; USD 63,000 - 80,000; Full time

Benefits offered by this job

Bonus eligible

Comprehensive benefits

Job summary

Integrated DNA Technologies (IDT) in Boulder, CO, seeks a Quality Assurance Specialist to administer and maintain the QMS, handle document control, deviations, and training, and support batch release activities on-site. The role requires a life sciences degree and QA experience in biotechnology.

The position reports to the QA Manager and offers bonus eligibility plus a comprehensive benefits package. Familiarity with SAP, MasterControl, and Maintenance Connection is a plus.

Qualifications

• Bachelor’s degree in life sciences (biology, chemistry, biochemistry, et cor related field).
• 1+ years of Quality Assurance experience in the manufacturing industry, especially in biotechnology and next-generation sequencing.
• Experience with ISO:9000/ISO:13485 and FDA QSR/cGMP standards.
• Proficiency with computers and Microsoft Office Suite.

Responsibilities

• Perform timely review and release of batch records, DHRs, and inspection results to ensure compliance with product specifications and procedures.
• Maintain and support document control and training processes within the eQMS, including reviews and approvals and record retention.
• Initiate, investigate, and support closure of quality events (Nonconformances, Deviations, CAPAs) using root cause analysis.
• Collaborate with Manufacturing, Logistics, Quality Control, and Supply Chain Planning to ensure compliance and continuous improvement.
• Participate in internal and external audits as needed.

Skills

Quality Assurance

Documentation

Computer proficiency

Education

Bachelor’s degree in life sciences

Tools

SAP

MasterControl

Maintenance Connection

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Integrated DNA Technologies (IDT), one of Danaher’s (https://danaher.com/our-businesses) 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. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Our team at Integrated DNA Technologies (IDT), is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more. At IDT, you’ll be part of a culture rooted in continuous learning and improvement—where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all.

Learn about the Danaher Business Syste m which makes everything possible.

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.

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, et cor 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 s
• It would be a plus if you also possess previous experience in:

• SAP, MasterControl, and/or Maintenance Connection systems

• The annual salary range for this role is between $ 63,000.00 - 80,000.00 USD Annual. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
• This job is also eligible for bonus/incentive pay.
• We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and Retirement Benefits to eligible employees.
• Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

#LI-LCS

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.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].