QA Specialist II

Radiometer; Fargo (ND); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Remote work eligible

Job summary

Aldevron, a Danaher operating company, is hiring a QA Release Specialist II to support final batch release and documentation review in a GMP environment. You will work with cross-functional teams to ensure compliance with cGMP and regulatory requirements at our Fargo, ND site.

The role emphasizes reviewing materials, collaborating across QA, QC, and Operations, and contributing to continuous improvement in quality documentation and procedures.

Qualifications

• Experience reviewing and auditing documentation in a regulated environment.
• Understanding of CPPs/CQAs and batch release criteria.
• Strong communication, critical thinking, and decision-making skills.

Responsibilities

• Review and evaluate batch documentation, production records, testing records, and supporting data for completeness and compliance with regulatory requirements.
• Evaluate evidence to determine CPPs/CQAs and other requirements for material disposition and final batch release.
• Identify and escalate quality issues that may impact product quality, patient safety, or regulatory compliance.

Skills

Quality systems

GMP experience

Auditing

cGMP knowledge

Education

Bachelor of Science in Life Science

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 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 escape 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.

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.

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 in:

• 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.

Benefits and Perks:

• 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.
• 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.
• 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.

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.

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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].

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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.

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