Quality Assurance Specialist - Labeling

At Aldevron we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated forwardthinking associates share this goal by combining bestinclass 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 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 located in Fargo ND and will be on site. At Aldevron we combine bestinclass products and servicewith the ideal operating environment to lay the groundworkfor vital new discoveries worldwide. You will be a part of the Operational Quality Assurance team and report to the Sr. Manager Operational QA responsible for Developing and implementing labeling processes and procedures and collaborating with crossfunctional 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 the creation approval and implementation (including reconciliation) of labels and labeling artwork including primary secondary and packaging components. Coordinate with internal stakeholders and external vendors to ensure timely and accurate labeling production including translations barcodes and serialization.
• Ensure that labeling content format and placement adhere to these requirements throughout the product lifecycle. Ensure compliance with labeling regulations such as 21 CFR PartEU Annex 13 EudraLex Vol 4 ICH Q7 ICH Q9 ICH Q10 and international guidelines.
• Establish and maintain labeling processes: Develop and maintain robust labeling processes and procedures to ensure compliance accuracy and consistency of labeling across product lines which includes creation issuance and reconciliation. Implement control mechanisms such as document control change management and review cycles to maintain labeling integrity.
• Collaborate with internal stakeholders: Work closely with Regulatory Affairs Quality Assurance and Manufacturing teams to ensure alignment on labeling requirements changes and challenges. Provide guidance and support to these teams on labelingrelated matters including artwork creation proofreading and artwork version control (if applicable).
• Stay informed about industry trends: Continuously monitor industry trends developments and best practices related to labeling regulations technology and artwork creation. Proactively identify opportunities for process improvements automation and efficiency gains in the labeling function.

The essential requirements of the job include:

• 5 years of relevant experience in drug product label/labeling required
• Experience with labeling equipment qualification and labeling process validation preferred.
• Bachelors Degree required; life science related field preferred.
• Track record of compliance in the application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Strong foundational knowledge in FDA and EU regulations specific to labels and labeling such as 21 CFR PartEU Annex 13 EudraLex Vol 4 ICH Q7 ICH Q9 ICH Q10 and international guidelines

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Join our winning team today. Together well accelerate the reallife impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

For more information visit www.danaher.

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