Title: Sr. QA Specialist - Labeling
Location: Fargo, ND (Can offer FULL relocation)
Position Summary:
A leading CDMO for the cell and gene therapy space is seeking a Quality Labeling SME to join their growing team! You will oversee all labeling activities throughout the product lifecycle. This includes managing the creation, approval, and implementation of labels and labeling artwork for primary, secondary, and packaging components. You will coordinate with internal teams and external vendors to ensure labels are produced accurately and on time, including translations, barcodes, and serialization.
Primary Responsibilities:
- Labeling Oversight: Manage the entire labeling process, ensuring accuracy and compliance from creation to implementation. Handle the reconciliation of labels and artwork.
- Regulatory Adherence: Ensure labeling content, format, and placement meet regulatory requirements such as 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q9, ICH Q10, and other international guidelines.
- Process Management: Develop and maintain effective labeling processes and procedures to ensure compliance, accuracy, and consistency across product lines. Implement control mechanisms like document control, change management, and review cycles.
- Team Collaboration: Collaborate with Regulatory Affairs, Quality Assurance, and Manufacturing teams to align on labeling requirements and changes. Provide guidance on labeling-related matters, including artwork creation and version control.
- Industry Monitoring: Stay informed about industry trends, developments, and best practices related to labeling regulations and technology. Identify opportunities for process improvements and efficiency gains.
Essential Qualifications:
- Experience: At least 5 years of experience in drug product labeling. Experience with labeling equipment qualification and process validation is preferred.
- Education: Bachelor's Degree required, preferably in a life science-related field.
- Regulatory Knowledge: Strong understanding of cGMP and GDP, with a proven track record of compliance with FDA and EU labeling regulations.
