Quality Label Project Coordinator

Company: Guerbet
Location: Raleigh
Posted on: June 25, 2022

Job Description:

OUR NEED:Responsible for coordination of all printed materials labeling deliverables (will vary by project), including labels, inserts, and cartons. These include but are not limited to label part number generation and approval of artwork per regulatory guidelines. Develop deliverable schedules and establish milestones for tracking progress. Interacts with internal cross-functional teams to provide input into labeling projects. Engages the global labeling group to meet company goals including label introduction and label improvement projects. Responsible for change control task closures and preliminary assessments. May participate in other documentation and label control roles.YOUR RESPONSIBILITIES:1. Responsible for the management of all documentation related to new labeling introduction and label revisions.
2. Coordinate and track the status of new/revised labeling following manufacturing planning schedule.
3. Provide editorial support and ensure quality of all document content; focus on clarity, accuracy, and consistency, while maintaining adherence to proper formats, regulatory requirement and company procedures and guidelines. Create, draft and revise SOP's and manufacturing batch records related to label changes.
4. Collaborate with cross-functional departments to ensure timely implementation of document change controls and requests.
5. Support tracking and communication of site metrics to management.
6. Implement initiatives to enhance the labeling revision process as fit.
7. Accountable for entry of document-related information into applicable logs, both manual and electronic for tracking and accountability purposes. Assure that any data tracking systems are kept current and are operating as efficiently as possible.
8. Assist in special projects, complete project tasks to effectively meet with project timelines.
9. Self-motivated, proactive, detail-oriented, and able to manage multiple tasks while still meeting deadlines.
10. Ability to successfully handle multiple competing priorities in a fast-paced, changing team environment.YOUR PROFILE:

• Bachelor's degree
• 2-3+ years in a pharma manufacturing GMP environment
• Excellent written and oral communication skills, detail oriented
• Strong analytical, organizational and CS service skills
• Outstanding technical writing, structural and project management skills
• Knowledge and experience in understanding regulations and guidelines of FDA, CFR, ICH, cGMP, and GDP pharma industry standards

Keywords: Guerbet, Raleigh , Quality Label Project Coordinator, Other , Raleigh, North Carolina