New · posted Oct 28
Danaher · Biotechnology
QA Specialist II
- Fargo, ND
- On-site
- Full-time
- Associate & Specialist
The role
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Aldevron, 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. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you’ll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential—one discovery at a time.
Learn about the Danaher Business System which makes everything possible.
The QA Release Specialist II is responsible for the following:
· Review and evaluate executed batch documentation, production records, testing records, and supporting data to ensure completeness, accuracy, and compliance with cGMP, cGDP, approved procedures, and applicable regulatory requirements.
· Evaluate documentation and supporting evidence to determine whether Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and other established requirements have been met to support material disposition and final batch release.
· Identify and escalate quality issues that may impact product quality, patient safety, regulatory compliance, or batch disposition, ensuring deviations and other quality events impacting release are appropriately investigated and resolved.
This position reports to the QA Release Supervisor and is part of the QA Release team within the Operational QA organization located in Fargo, ND and will be an on-site role.
What you need
The essential requirements of the job include
· A minimum of one (1) year of experience in a Quality or auditing role within a regulated or GMP-compliant environment.
· Bachelor of Science degree preferred, with a life science discipline preferred, or equivalent work experience.
· Effective communication, critical thinking, and decision-making skills, with the ability to work independently and collaboratively, evaluate potential risks to product quality or regulatory compliance, manage multiple priorities, and meet established timelines.
Travel, Motor Vehicle Record & Physical/Environment Requirements
- No travel is required as this is an on-site position.
- Ability to use computer, monitor, headset, mouse/keyboard, sit/stand desk, and copier/scanner.
- Ability to lift, move, or carry equipment up to 50lbs.
- undefined
It would be a plus if you also possess previous experience innice to have
- Any relevant experience in validation processes, procedures, & concepts.
- US Code of Federal Regulations (CFR) and/or EU Regulations
- cGMP, GMP, manufacturing & related equipment, QC testing and related equipment.
Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
At Aldevron we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Aldevron can provide.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) 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.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. 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.
The U.S. EEO posters are available here.
For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.
What you'll do
In this role, you will have the opportunity to
· Serve as a QA subject matter expert in the review and disposition of materials and products, including final batch release, while managing multiple review activities and established timelines.
· Collaborate with cross-functional partners, including Quality Assurance, Quality Control, Operations, Manufacturing, and other supporting functions, to facilitate documentation review, correction, finalization, and disposition activities.
· Support continuous improvement by tracking and trending documentation errors, providing task-specific training, and contributing to the development or refinement of work instructions, training materials, procedures, and other quality documentation.
Pay and benefits
Danaher didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Paid time off
Medical insurance
Dental insurance
Vision insurance
401(k)
Where you'll work
Fargo, NDOn-siteOpen in Maps (opens in a new tab)
More jobs in Fargo, NDEqual opportunity, accessibility and legal noticesDanaher's statements, word for word
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.
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 [email protected].
Job intelligence
The context around this role
Live data · October 28, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US181 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $59,000 | $81,000 | $95,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 961 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Danaher's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- GMP and compliance6
- Documentation and SOPs6
- Lab testing and methods2
- Quality systems and risk2
- Investigations and CAPA1
- Validation and qualification1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Danaher on Regulatory Jobs
- 58
- Open roles
- 48
- Distinct roles
- 20
- Locations
By discipline
- Quality53 91%
- Regulatory4 7%
- Compliance & Safety1 2%
By level
- Senior & Principal28 48%
- Associate & Specialist23 40%
- Manager5 9%
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QA Specialist II at Danaher
Open until filled.