What are the responsibilities and job description for the Labeling Change Control Analyst position at Stefanini North America and APAC?
Looking for Labeling Project Leader (Medical Device/Pharmaceutical)
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.
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
QUALIFICATION:
- 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.
- Bachelor's degree or equivalent required.
- Minimum of 3-5 years professional experience required.
- Labeling and change control experience required.
