Quality Assurance Specialist - Labeling

Aldevron LLC; Ontario; Remote; CAD 60,000 - 100,000; Full time

Job summary

An innovative firm is seeking a dedicated Quality Assurance professional to manage and enhance labeling processes. This role involves overseeing the entire product lifecycle, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to align strategies with branding and regulatory requirements. With a focus on continuous improvement and efficiency, this position offers the chance to make a significant impact in the life sciences sector. If you're passionate about advancing science and improving human health, this opportunity is perfect for you.

Qualifications

• 5+ years of experience in drug product labeling.
• Strong knowledge of FDA and EU labeling regulations.

Responsibilities

• Manage labeling activities throughout the product lifecycle.
• Ensure compliance with regulatory standards for labeling.
• Collaborate with internal teams on labeling requirements.

Skills

Regulatory Compliance

Labeling Strategies

Document Control

Quality Assurance

Process Validation

Education

Bachelor’s Degree in Life Science

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 located in Fargo, ND, and will be on-site. You will be part of the Operational Quality Assurance team and report to the Sr. Manager, Operational QA. Your responsibilities include developing and implementing labeling processes and procedures, and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align with regulatory requirements and company branding.

This is a remote position requiring frequent travel to Fargo, ND.

In this role, you will have the opportunity to:

1. Manage labeling activities throughout the product lifecycle: oversee creation, approval, and implementation of labels and artwork, including primary, secondary, and packaging components. Coordinate with stakeholders and vendors to ensure timely and accurate labeling, including translations, barcodes, and serialization.
2. Ensure labeling content, format, and placement comply with regulatory standards throughout the product lifecycle. Maintain adherence to regulations such as 21 CFR Parts 210, 211, 610; EU Annex 13; EudraLex Vol 4; ICH Q7, Q9, Q10, and other international guidelines.
3. Establish and maintain labeling processes: develop robust procedures to ensure compliance, accuracy, and consistency across product lines. Implement control mechanisms like document control, change management, and review cycles to maintain labeling integrity.
4. Collaborate with internal teams: work closely with Regulatory Affairs, Quality Assurance, and Manufacturing to ensure alignment on labeling requirements and changes. Provide guidance on artwork creation, proofreading, and version control.
5. Stay informed on industry trends: monitor developments in labeling regulations, technology, and artwork creation. Identify opportunities for process improvements, automation, and efficiency gains.

The essential requirements of the job include:

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

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Join our team today. Together, we’ll accelerate the impact of tomorrow’s science and technology. We partner globally to solve complex challenges, bringing 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 all forms. Our associates, customers, and shareholders bring unique perspectives that enrich our work environment and market approach.

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We provide reasonable accommodations for individuals with disabilities during the application and employment process. Please contact [e-mail] for assistance.