Accountabilities & Responsibilities:- Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Plans, schedules, conducts, and coordinates detailed phases of the labeling process in a part of a major project or total project of moderate scope.
- Prepares, creates, and controls labels and Instructions for Use according to procedure, including the updates to these documents throughout the product life cycle. Tracks and maintains labeling documents using process tools for revision control.
- Reviews labeling documents to ensure accuracy, including formatting of text and graphics conform to established guidelines for consistency, technical construction, and overall presentation.
- Initiates and/or implements Change Control Requests pertaining to labeling updates. Follow through on open Change Control Requests and evaluate the impact assessment related to labeling updates.
- Performs upload and maintain the applicable UDI databases (i.e. FDA UDI GUDID, EUDAMED).
- Investigate, contribute and support new labeling process technologies of moderate scope.
- Prepare all necessary paperwork and documentation for all projects undertaken.
- Strive for continuous improvement and consistency in deliverables.
- Communicate with internal and external customers regarding ongoing labeling updates.
- Executes new labeling in support of new product development and current production. Collaborate with cross-functional teams to ensure labeling deliverables are on-track with each project.
- Prepares and manages labeling translations activities.
- Collaborates with cross-functional teams to review product specifications evaluating product characteristics, special-handling and safety requirements, and type of materials required for labeling development.
- Supports the execution of Packaging and Label Validation Plans and Reports.
- Ensures packaging and labeling follows regulatory, customer and specification requirements and standards. Provides support with internal and external Regulatory submission package.
- Supports the validation of packaging equipment and labeling equipment to include IQ, OQ and PQ.
- Support Value Stream manufacturing teams for packaging and labeling projects.
- Provides technical support for label printing and database management.
- Performs other duties as required.
Education & Experience:- Minimum Education & Experience: Bachelor's degree in a related field or 3+ years of experience of GMP, FDA, Change Control process
Knowledge & Skills:Skills: - Strong written and oral communication skills.
- Strong attention to detail.
- Strong organizational and time management abilities
- Demonstrated ability to work in a team environment.
- Strong understanding of Regulatory labeling landscape.
Specialized Knowledge:
- Strong proficiency with Microsoft Office
- Strong proficiency with Adobe InDesign
- Strong proficiency with Adobe Illustrator
- Knowledge and understanding of label creation software
- Strong understanding of Regulatory labeling landscape.
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer's success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.
