Quality Specialist I
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 and Regulatory Affairs located in Madison, WI and will be an Onsite 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 Sr. Mgr. of Quality Assurance.
In this role, you will have the opportunity to:
- Review/approve and generate reports on documents as well as maintain, store, and coordinate archiving of documents
- Support and Maintain quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products
- Maintain quarantine locations and quarantined material and follow up on disposition of quarantined materials
- Support Aldevron’s audit program and provide support during audits performed of Aldevron’s Madison by internal and 3rd party auditors, clients and regulatory agencies
- As needed, assist with creation and modification of Quality System procedures and related documentation
- Assist with processing activities related to the Deviations (Quality Events), Complaints, Changes and CAPA program(s)
- Support the Quality Systems Manager by ensuring effective implementation and maintenance of quality systems
The essential requirements of the job include:
- Bachelor’s (or equivalent) degree in science or related field or equivalent experience
It would be a plus if you also possess previous experience in:
- Conduct Receipt Inspection activities for critical incoming materials
- Operating in a professional office environment
- Quality Assurance or Regulatory Compliance experience in GxP environment is a plus
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 tools and the stability of a tested organization.