Quality Improvement Specialist Jobs in North Dakota

INTRODUCTION

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.

ROLE AND RESPONSIBILITIES

The QA Release & Validation Specialist is responsible for reviewing & approving the following:

• Executed batch records & batch disposition
• QC testing assays
• Executed validation documentation

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:

• Review production and test records for completeness and accuracy, ensuring data supports release, meets SOP and applicable Regulations, and all deviations have been appropriately investigated and resolved.
• Review Equipment, Process, Computer Validation, and Bioanalytical Method Development Validation executed documentation to ensure compliance with approved protocols, quality standards, and applicable Regulations.
• Serve as the QA subject matter expert and ensure products, testing, and validation activities not meeting specifications are dispositioned appropriately.

BASIC QUALIFICATIONS

The essential requirements of the job include:

• A minimum of one (1) year of experience in a Quality or auditing role
• Experience working in a regulated or GMP-compliant environment.
• Bachelor of Science or life science discipline preferred or equivalent experience.

PREFERRED QUALIFICATIONS

It would be a plus if you also possess previous experience in:

• US Code of Federal Regulations (CFR) and/or EU Regulations
• cGMP

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.

COMPENSATION

The annual salary range OR the hourly range for this role is $43,500.00 - $72,000.00 USD. 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 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.