Overview
Sr. Labeling Specialist – Drug Product Jobs in Fargo, North Dakota, USA at Aldevron
Join us as a
Sr. Labeling Specialist – Drug Product
at
Aldevron
At Aldevron, we are dedicated to shaping the future of medicine by advancing science in meaningful ways. Our team combines best-in-class products and services with an optimal environment to enable vital discoveries worldwide. We value diversity and believe people are our most valuable asset.
This position, part of the Quality Assurance team, is remote with frequent travel to Fargo, ND. You will develop and implement labeling processes, collaborate with cross-functional teams, and ensure compliance with regulatory standards.
Key Responsibilities:
Manage labeling activities throughout the product lifecycle, including creation, approval, and reconciliation of labels and artwork.
Ensure labeling content and format adhere to regulatory requirements such as 21 CFR Part 210, 211, 610, EU Annex 13, and ICH guidelines.
Develop and maintain robust labeling processes, including document control and change management.
Collaborate with Regulatory Affairs, Quality Assurance, and Manufacturing teams on labeling requirements and changes.
Stay informed on industry trends and identify opportunities for process improvements.
Minimum Requirements:
5+ years of relevant experience in drug product labeling.
Bachelor’s Degree in a life sciences or related field.
Experience with labeling equipment qualification and process validation preferred.
Strong knowledge of FDA and EU labeling regulations and compliance with cGMP and GDP.
Join our team to help accelerate the impact of science and technology. For more information, visit
We are committed to equal opportunity employment and providing reasonable accommodations for applicants with disabilities. Contact  for assistance.
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Title: Sr. Labeling Specialist – Drug Product
Company: Aldevron
Location: Fargo, North Dakota, USA
Category: Healthcare (Data Scientist), Quality Assurance – QA/QC (Data Analyst)
