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Danaher Corporation Operational Quality Assurance Specialist I in Fargo, North Dakota

Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy. We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world’s most important and challenging solutions to benefit us all. We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world.

Aldevron is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

This position is part of the Quality Assurance department located in Fargo, ND and will be onsite working a first shift position. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Quality Assurance Team and report to the Operational Quality Assurance Manager. The Operational QA Specialist I activities include but not limited to; releasing manufacturing rooms for use, review to ensure Environmental Monitoring (EM) occurred, review of solution preparation, review of quality control documentation, and live documentation review of manufacturing processes and other quality department functions.

In this role, you will have the opportunity to:

  • Provide real-time support and oversight of manufacturing operations

  • Perform GDP review of manufacturing supporting documentation batch records and protocols at time of execution.

  • Responsible for review of Good Documentation Practices (GDP) on executed documentation.

  • Oversee label generation to ensure traceability of final material

  • Releasing manufacturing rooms following required reviews and confirming acceptance criteria have been met

  • Responsible for ensuring that solution preparation is performed in accordance with internal requirements and meets final specifications.

  • Collaborate inter and intra-departmentally to resolve outstanding issues within required time-frames.

    The essential requirements of the job include:

  • Bachelor of Science, preferred, life science related field preferred or equivalent experience

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

  • Quality related experience is preferred.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

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 value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.