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Danaher Corporation QA 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. 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 Quality Assurance Release Supervisor and responsibilities include quality review of supporting documentation completed for production, testing, labeling, and shipping in order to determine if all critical process parameters (CPPs) and critical quality attributes (CQAs) have been met. Upon completion of review, this individual will determine if the evidence supports release of associated materials and if the materials are suitable for use and shipping.

In this role, you will have the opportunity to:

  • Responsible for the review of supporting production and testing documentation for completeness and accuracy. This individual must be able to identify deviations from procedure and confirm that all quality events have been appropriately investigated and closed related to the documents reviewed.

  • Responsible for tracking incoming documentation and document movement within the Quality Assurance Department.

  • Support Quality Assurance team by assigning appropriate tasks within required tracking tools and Quality Management System to support lot release.

  • Work with staff across multiple departments during review, correction and finalization of documentation.

  • Responsible for tracking and trending of documentation errors

  • Ability to manage multiple documents simultaneously that are in different stages of review and/or approval

  • Maintains strong communication networks with peers

The essential requirements of the job include:

  • Bachelor of Science (Life science related preferred). Equivalent experience may be considered.

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

  • This is an entry level position, but any 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.