Quality Assurance Specialist - Labeling

Aldevron LLC; Fargo (ND); Remote; USD 75,000 - 95,000; Full time

Job summary

Aldevron LLC is seeking a Quality Assurance Specialist to join their team remotely. This role involves managing regulatory labeling processes and ensuring compliance with FDA and EU regulations, necessitating strong collaboration skills and experience in drug product labeling. Candidates should possess a Bachelor's degree in a relevant life science field and have a minimum of 5 years experience in the sector.

Qualifications

• 5+ years of relevant experience in drug product labeling.
• Strong knowledge of FDA and EU labeling regulations.
• Experience with labeling equipment qualification preferred.

Responsibilities

• Manage labeling activities across product lifecycle, ensuring compliance and accuracy.
• Develop and maintain labeling processes and procedures, collaborating with cross-functional teams.
• Stay informed about industry trends to identify opportunities for process improvements.

Skills

Regulatory Compliance

Document Control

Process Improvement

Education

Bachelor’s Degree in a life science-related field

Job description

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.

Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development, and delivery of solutions that safeguard and improve human health.

This position is part of the Quality Assurance team and will be remote with frequent travel to Fargo, ND. You will report to the Sr. Manager, Operational QA, and be responsible for developing and implementing labeling processes and procedures, collaborating with cross-functional teams including Clients, Regulatory Affairs, and Marketing to develop labeling strategies that meet regulatory requirements and align with company branding.

Key Responsibilities:

1. Manage labeling activities throughout the product lifecycle, including creation, approval, and implementation of labels and artwork, ensuring accuracy and compliance.
2. Ensure labeling content, format, and placement adhere to regulatory requirements such as 21 CFR Parts 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, Q9, Q10, and international guidelines.
3. Develop and maintain robust labeling processes and procedures for compliance, accuracy, and consistency, including document control and change management.
4. Collaborate with Regulatory Affairs, Quality Assurance, and Manufacturing teams to ensure alignment on labeling requirements and changes.
5. Stay informed about industry trends and identify opportunities for process improvements, automation, and efficiency gains in labeling.

Minimum Requirements:

1. 5+ years of relevant experience in drug product labeling.
2. Experience with labeling equipment qualification and process validation preferred.
3. Bachelor’s Degree in a life science-related field.
4. Proven compliance with cGMP and GDP standards.
5. Strong knowledge of FDA and EU labeling regulations.

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Join our team to accelerate the impact of science and technology. We partner globally to solve complex challenges and bring science to life.

For more information, visit www.danaher.com.

Danaher Corporation and its subsidiaries are committed to equal opportunity employment and value diversity in our workforce. Reasonable accommodations are available for applicants with disabilities. Contact [e-mail] for assistance.