Sr. Labeling Specialist

Danaher; Ontario; Remote; CAD 70,000 - 90,000; Full time

Job summary

A leading company in the life sciences sector is seeking a Quality Assurance professional to manage labeling processes and ensure compliance with regulations. The role involves collaboration with cross-functional teams and requires a strong background in labeling and regulatory practices. This position offers remote work with travel.

Qualifications

• 5+ years of relevant experience in drug product label/labeling.
• Proven compliance with cGMP and GDP practices.

Responsibilities

• Manage labeling activities throughout the product lifecycle.
• Ensure labeling content complies with applicable regulations.
• Collaborate with internal teams on labeling requirements.

Skills

Compliance

Labeling Regulations

Project Management

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 you are 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. You will 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 align with regulatory requirements and company branding.

In this role, you will have the opportunity to :

• Manage labeling activities throughout the product lifecycle : oversee creation, approval, and implementation of labels and artwork, including translations, barcodes, and serialization; coordinate with stakeholders and vendors for timely and accurate labeling.
• Ensure labeling content, format, and placement comply with applicable regulations such as 21 CFR Parts 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, Q9, Q10, and international guidelines.
• Establish and maintain labeling processes : develop procedures to ensure compliance, accuracy, and consistency; implement control mechanisms like document control, change management, and review cycles.
• Collaborate with internal teams : work closely with Regulatory, Quality Assurance, and Manufacturing to ensure alignment on labeling requirements and changes; provide guidance on artwork creation, proofreading, and version control.
• Stay informed about industry trends : monitor developments in labeling regulations, technology, and artwork creation; identify opportunities for process improvements and automation.

The essential requirements of the job include :

• 5+ years of relevant experience in drug product label / labeling.
• Experience with labeling equipment qualification and process validation is preferred.
• Bachelor’s Degree in a life science-related field is required.
• Proven compliance with cGMP and GDP practices.
• Strong knowledge of FDA and EU regulations related to labels and labeling, including 21 CFR Parts 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, Q9, Q10.

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Join our team to help 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 affiliates are committed to equal opportunity employment and value diversity in our workforce. We provide reasonable accommodations for individuals with disabilities. Contact us at [e-mail] for assistance.