Labeling Project Leader

Job Description:

• Provide analytical support to the Product Authentication and Labeling organization under minimal supervision.
• Responsible for gathering and managing label change control data within the program.
• Track labeling change deliverables across multiple plants, product codes, create dashboards for management and escalate issues as needed.
• Create process flows diagrams using MS Visio or similar tools to map current and to-be process, dashboarding skills.
• Create process to manage and track labeling changes to ensure label changes are issued in time to meet compliance deadlines.
• Monitor the progress of the label changes and act as a liaison between the project manager and label team.
• Develops and maintains labeling dashboard & status reports.
• Assesses project/management issues and develops resolutions in order to meet objectives, which may include quality, customer satisfaction, productivity and costs .
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

List knowledge, skills, and/or abilities required.

• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• Strong interpersonal skills and great attention to detail are necessary.
• Strong analytical skills, process improvement, problem solving & critical thinking.
• Ability to respond to customers in a timely manner and communicate effectively.
• Must be able to handle multiple projects concurrently.
• Must be a strong team player with good verbal and written communication skills.
• Proficient in Microsoft Word, Excel, PowerPoint, Visio etc
• Experience with labeling in Serialization/UDI preferred, familiarity with electronic change control systems, labeling management systems, PLM etc a plus.
• Knowledge of FDA Regulations, Application of Good Manufacturing Practices and Good Documentation Practices preferred.

Include the education and experience that is necessary to perform the job satisfactorily.

• Bachelor's degree or equivalent required.
• Minimum of three to five years professional experience required.
• Labeling and change control experience required.