What are the responsibilities and job description for the Labeling Project Leader II (Medical Devices) position at DivIHN Integration Inc?
Job Description
Job Description
For further inquiries regarding the following opportunity, please contact our Talent Specialist
Hema Malini at 630 847 0275
Title : Labeling Project Leader II (Medical Devices)
Location : Round Lake, IL
Duration : 10 Months
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.
About us :
DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
