Highlights
Duties: Serve as the Global Labeling and Packaging team member for Labeling and packaging development intiatives, including but not limited to NPD (new product development), M&A, CPI (Core product improvement) and UDI tasks. Coordinate services and works effectively with vendors and suppliers of services (e.g., translation vendors, print vendors, instrument and/or implant suppliers) to ensure execution of high-quality deliverable for labeling and packaging.
Numbers & Facts
| Location | Warsaw, IN |
| Industry | Staffing/Employment Agencies |
| Salary | $1–$46.66 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Title: Labeling Assoc Specialist
Location: Warsaw, IN 46580
Duration: 12 Months
Duties:
Skills:
Education:
Location: Warsaw, IN 46580
Duration: 12 Months
Duties:
- Serve as the Global Labeling and Packaging team member for Labeling and packaging development intiatives, including but not limited to NPD (new product development), M&A, CPI (Core product improvement) and UDI tasks.
- Work with Regulatory, Development, Brand, Manufacturing and Other departments to develop/create labeling and packaging that complies with US, EU, and UDI labeling and packaging regulations and requirements, as required.
- Ensures compliant labeling creation, accurate data loaded to labeling systems, approval, maintenance, and label release, including appropriate procedures, work instructions, and forms.
- Coordinate services and works effectively with vendors and suppliers of services (e.g., translation vendors, print vendors, instrument and/or implant suppliers) to ensure execution of high-quality deliverable for labeling and packaging.
- Complete Destination labeling, eLabeling for all labeling documents such as but not limited to IFU, Surgical Technique, Creating Material specification and formats for printed IFU
- Demonstrates medical packaging design and development execution within a multi-disciplinary project team desired with minor guidance.
- Assists/Conducts and owns testing to support project activities with minor guidance.
- Leads design control process related documentation to support projects with guidance.
- Serve as point of contact for Global Labeling and Packaging Development team for M&A sites
- If needed, travel to other sites to perform onsite activities like requirement gathering, process understanding or implementation.
Skills:
- Broad knowledge and understanding of Product Labeling and Packaging regulations for US and OUS regions.
- Demonstration of strong problem solving skills; able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner.
- Strong ability to build and strengthen relationships with other areas of the organization (i.e. Marketing, Packaging, Development, IT) and other Business Sites.
- Good understanding of medical packaging design and development execution
- Good understanding of how labeling systems communicate with other business systems
- Exceptional attention to detail, organization, and multi-tasking skills.
- Understand the overall business environment, the orthopedic industry, and the marketplace
Education:
- Bachelor s degree in Science or Technical field with 0+ years experience in a labeling or relevant capacity.
- Associate degree in Science or Technical field with 4+ years experience in a labeling or relevant capacity.
- High School diploma or equivalent required with 6+ years of experience in a labeling or relevant capacity.
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.