Danaher Corporation Stability Specialist 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.
Write and maintain stability protocols and SOPs in support of the stability program.
Write Quality Events, CAPAs, Change Controls, OOS investigations or OOT investigations for stability samples under the Stability Program manager guidance.
Responsible on the implementation of regulatory requirements for the stability program documentation.
Responsible of routing for approval of the stability program documents.
Organize, assemble, and route documentation to support Stability Program document review and approval as required by Quality Systems management.
Ensure data is evaluated, including the creation, review, and trending, to meet company, industry and regulatory requirements.
Collaborate with other functions including Quality Assurance, Regulatory Affairs, Quality Control, and Business Units to ensure the Stability Program is effectively supported.
Supports regulatory filings by providing data for appropriate sections.
2 years of experience in a relevant professional field.
Bachelor's Degree with a focus in Chemistry, Sciences, Pharmacy or similar discipline preferred.
Experience in a Quality Assurance or Quality Control function in a regulated industry (Pharmaceutical, Medical Device, OTC Drug, Cosmetic, cGMP etc.) 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 email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.