Label Change Specialist
- Responsible for implementing and maintaining the effectiveness of the quality system by delivering the "perfect label" to our customers through an effective and efficient label change management process. The Perfect Label is defined as compliant with content requirements and timely implementation, both internal and external to AbbVie.
- Scope of label changes includes Regulatory Affairs for labeling submissions, AbbVie manufacturing sites, third party manufacturers and third party contracts.
- Complete work according to established priorities, policies, practices and procedures to assure deliverables meet requirements.
- Collaborate and communicate with key stakeholders in the label change process for production and submission artwork to prioritize deliverables.
- Comply with the labeling change schedule to meet established timelines. Communicate and negotiate exceptions to planned delivery dates.
- Interact with key stakeholders such as Regulatory Affiliates and Packaging Engineering, as needed, to successfully execute label change requests and Proofreading for the verification of developed label copy against the source documents.
- Ensure tasks are completed according to Right First Time principles
- Evaluate the impact of a label change on associated labels and manufacturing operations.
- • Ensure completeness, accuracy, and control of changes in labeling including maintenance of labeling related specifications and documentation associated with these specifications.•
- Work closely with Graphics in the creation of label artwork, mock ups utilized for regulatory submissions, and assist commercial, as required, in the development of label designs for packaging and labeling commodities.
- Bachelor's Degree in Business / Engineering/Sciences preferred. Equivalent successful industry experience (minimum 2 years) can be considered (see below for guidance).
- Minimum of 2 - 4 years combined experience from totals: Quality/Regulatory- 2 years, Operations - 2 years, Pharmaceutical/Device Regulations - 2 years.
- Ability to motivate and influence others over whom they have no direct authority.
- Aware of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labeling Quality System.
- Ability to logically reason, solve problems, and make decisions on key issues independently.
- Self-motivated and strong focus on details and accuracy
- Strong written and interpersonal communication skills.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled