Danaher Hiring for Document Specialist I Job at Fargo, ND Full Time

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.

Job Summary:
The Document Control Specialist is responsible for performing all duties related to the management of all documentation within the organization. This individual will create, route, approve, maintain, and archive both paper and electronic documents and for maintaining the accuracy of our Electronic Quality Management System (eQMS). This individual will help drive all outstanding documentation to closure by interacting with other departments in order to provide any necessary support and guidance to facilitate approval and closure so that the enhancements are realized within the projected timeframe.

Responsibilities

Create, route, maintain and archive all site GMP documentation, which includes change controls, quality events, corrective and preventative actions (CAPAs), customer complaints, SOPs, batch records, master batch records, etc.

Manage periodic/biennial reviews.

Manage batch record issuance and verification.

Write, review, and revise standard operating procedures as needed.

Develops, justify, and implement process improvements.

Qualifications

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

Quality related experience is preferred

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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.