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.
Position Overview
This position is part of the Quality Assurance team located in Fargo, ND and will be on site. 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 cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align with regulatory requirements and company branding.
Key Responsibilities
- 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 compliance requirements throughout the product lifecycle, including regulations such as 21 CFR Part 210, 211, 610, EU 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 labeling-related 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.
Essential Requirements
- 5+ years of relevant experience in drug product label/labeling required.
- Experience with labeling equipment qualification and labeling process validation preferred.
- Bachelor’s 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 Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q9, ICH Q10, and international guidelines.
At Danaher, we bring together science, technology, and operational capabilities to accelerate the real-life impact of tomorrow’s 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology, and beyond. For more information, visit www.danaher.com.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace, and throughout the markets we serve.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
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