OQA Specialist I

Aldevron; Fargo (ND); On-site; USD 42,000 - 65,000; Full time

Job summary

Aldevron in Fargo, ND, is seeking an Operational Quality Assurance Specialist I to inspect production activities, resolve nonconformances, and review live documentation on the shop floor. The role is on-site with a typical 8:00 am to 4:30 pm schedule, Monday through Friday, reporting to the OQA Supervisor.

The ideal candidate has a high school diploma (BS preferred) and 0–1 years of experience in a biological manufacturing setting.

Qualifications

• High school diploma required; Bachelor of Science preferred.
• 0–1 year of experience; entry level.
• Biological manufacturing environment familiarity is a plus.

Responsibilities

• AQL sampling of finished product to confirm conformance to the required specification.
• Quality support and oversight of manufacturing operations on the shop floor.
• Provide real-time assistance in the resolution of Quality challenges during routine operations.
• On-the-floor quality oversight of manufacturing, inspection, label generation, and timely input to enable compliant operations.
• Maintains effective and collaborative internal customer relationships.
• Additional responsibilities as assigned.

Skills

Quality assurance

GMP

Sampling

Shop floor

Education

High School Diploma

Bachelor of Science

Tools

MS Office

Documentation systems

Job description

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

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-impacting one discovery at a time. Learn about the Danaher Business System which makes everything possible. The Operational Quality Assurance Specialist I is responsible for both visual and physical inspection of production activities, product nonconformance resolution, live documentation review on the shop floor, and other quality department functions. This position reports to the OQA Supervisor and is part of the Operational Quality Assurance team located in Fargo, ND and will be an on-site role. SHIFT: M-F 8:00 am - 4:30 pm.

In This Role, You Will Have The Opportunity To

• AQL sampling of finished product to confirm conformance to the required specification
• Quality support and oversight of manufacturing operations on the shop floor
• Provide real-time assistance in the resolution of Quality challenges during routine operations
• Provides 'on-the-floor' Quality oversight of manufacturing, inspection, label generation, and provides timely input to enable compliant and timely operations
• Maintains effective and collaborative internal customer relationships
• Additional responsibilities as assigned

The Essential Requirements Of The Job Include

• High school diploma required. Bachelor of Science preferred, preferably in a biological field.
• 0-1 years of experience, this is an entry level position

Physical/Environment Requirements

• This position operates in a biological manufacturing environment with some work in an office setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets.

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.

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].