Hello this is Komal from Intellectt we have an opening for a Labeling Specialist in Plymouth, MN. Please find the job details and description below and if interested You can reach me at komal@intellectt.com or call me at +1(732)-813-9025.
Role: Labeling Specialist
Location: Plymouth, MN - 55442
Duration: 11 Months on W2
Shift Timings: 8 AM to 5 PM
Job Description
Experience: 5-7
Education: Bachelor level degree in Communications, Regulatory, Business, Mathematics or equivalent combination of education and work experience.
Duties
- Create and manage labeling and UDI change processes within the document management systems.
- Create and modify product labels or other labeling materials ensuring compliance to all regulatory, legal and medical requirements.
- Following the established design format, labeling and UDI inconsistencies to meet applicable requirements and project timelines.
- Facilitates end-user training and assists in identifying resolution business and technical problems.
- Performs analysis and audits of UDI & or Labeling data to support regulatory compliance and cross functional business requirements.
- Manage UDI master data and workflow via internal IT systems.
- Manages concurrent deadlines and meets deadlines for assigned work/tasks. - Analyze and interpret large data sets and identify methods of resolution. - Complies to world-wide labeling and UDI regulations and cross-functional business requirements.
- Comply with company initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), RDA & world-wide regulations, business requirements, company policies, and operating procedures.
Requirements
- Experience with Microsoft Office Applications (Outlook, Word, Excel, PowerPoint)
- Able to manage multiple concurrent deadlines / shifting priorities
- Experience or desire working in a regulated environment or industry (eg: manufacturing, quality, etc)
Preferred Experience
- Previous experience in label design work, with preference in any of the following labeling design systems: Loftware, Bartender, enLabel
- Experience working with document control systems, especially Windchill
- Design experience in the Adobe Acrobat Create Suite, namely Adobe Illustrator, InDesign, and/or Photoshop Onsite, hybrid, or remote position.
- Onsite position (M-F) Required education level/certifications. Bachelor’s Daily tasks/duties and department interactions. - Perform label design work based on project needs
- Manage documentation change orders to create or revise labeling content
- Engage with project teams (both local and remote) to support individual project needs