OQA Lead

MedDeviceJobs; Fargo (ND); On-site; USD 90,000 - 130,000; Full time

Job summary

Aldevron, a Danaher operating company, is seeking an OQA Lead to execute batch record reviews, ensure GMP compliance, and support deviation investigations within the Quality Assurance team on-site in Fargo, ND. The role emphasizes timely, accurate documentation and adherence to GDP practices.

Successful candidates will review documents, assess quality standards, and contribute to overall GMP manufacturing processes, ensuring data integrity and ALCOA++ compliance where applicable.

Qualifications

• Must be able to independently perform batch record review and assess GMP documentation for quality.
• Experience with deviation investigations and change controls is preferred.
• Knowledge of GDP and data integrity/ALCOA++ principles is a plus.

Responsibilities

• Independently perform batch record review of GMP manufacturing documents.
• Assess GMP documents for quality and accuracy; participate in deviations investigations.
• Assist with tasks to complete GMP manufacturing processes.

Skills

Batch record review

GMP compliance

Quality investigations

Documentation review

Data integrity

ALCOA++ principles

GDP knowledge

Education

High school diploma

BS in Biology or Microbiology or related field

Job description

Bring more to life.

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

AtAldevron, one ofDanaher’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. Andby harnessingDanaher’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 theDanaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

TheOQA Leadis responsibleforexecuting batch record review, ensuring Good Manufacturing Practices (GMP) are met, troubleshooting manufacturing events, partaking in deviation investigations, and associated duties that support accurate and reliable batch record generation.

This positionreports to the second shift OQASupervisor andis part of theQuality Assurance department located in Fargo, ND and will be an on-site role.

In this role, you will have the opportunity to:

• Independently perform batch record review of documents generated within GMP manufacturing.
• Assess GMP documents for quality and accuracy, and play an integral role in investigations into deviations that may present themselves during GMP activities.
• Assist with tasks associated with overall completion of GMP manufacturing.

The essential requirements of the job include:

• Hish school diploma. Bachelor of Science in Biology, Microbiology, or related work experience preferred.
• Independently perform batch record review as assigned.
• Accurate and timely review of documentation with the ability to assess documentation and GMP activities for quality standards upheld by Aldevron.

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

• Working in a GMP environment that emphasizes Good Documentation Practices (GDP).
• Review of Quality documentation such as batch records, laboratory records, deviations, investigation, and change controls.
• A previous bioengineering Quality field centered around data integrity and ALCOA++ principles.

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 atDanaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

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.

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) .

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 (https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc) .

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].