What are the responsibilities and job description for the Sr. Labeling Specialist (Pharma OR FDA) position at Intellectt Inc?
Role: Sr. Labeling Specialist
Location: Fargo, North Dakota
Duration: 12 Months
Requirements
Location: Fargo, North Dakota
Duration: 12 Months
Requirements
- 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 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.
- 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.
- Manage labelling activities
- Labelling content verification
- Work closely with Regulatory Affairs, Quality Assurance, and Manufacturing teams
