Sr Labeling Systems Specialist

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Summary:

Responsible for managing Global Labeling systems, labeling approval systems/workflows and labeling processes to ensure systems are operating reliably, producing accurate data, and meeting regulatory and Hollister standards for finished goods labeling, as well as coaching and developing Labeling Specialists/Designers and employees utilizing the systems. Own and maintain Global Labeling system procedures to assure the integrity of product labeling (domestic and internationally) for all products manufactured at or for Hollister.

Provide oversight and assistance with understanding and implementation of global labeling system(s) responsibilities: loading and maintenance of label elements and labeling requirements; maintenance of label templates, formats and label types; usage of appropriate barcodes to meet AIDC requirements; parsing of UDI label elements and maintenance; creation and maintenance of label data sets for each label; creation and release of finished goods product labels for production use;

label review and approval system/process; support labeling data downloads for UDI submissions across the world.

Lead and SME for company’s Veeva Vault process and approvals for labeling materials.

Lead and act as Labeling SME for labeling related CAPAs and PMRAs (Post Market Risk Analysis) investigations.

Support and troubleshoot printing issues and/or errors from the different Hollister sites and/or external contract manufacturers related to the Global Labeling System and collaborate with cross-functional teams to identify solutions and avoid production discontinuation or stock-outs.

Hollister Incorporated operates in hybrid work environment.

Responsibilities:

• Ensure timely and satisfactory completion of labeling system launches, projects, and initiatives.
• Deploy Global Labeling System(s) at other Hollister Inc. sites, vendors and suppliers; ensure other labeling systems and processes are set up and running efficiently.
• Work with IT, Regulatory Affairs, Labeling Team and other cross functional teams globally as needed to develop and launch labeling systems that comply with US, EU and/or ROW regulations. Support and execute validation test scripts, label migration, creation and consolidation of label templates as needed, etc. and support integration with other systems within Hollister.
• Act as the lead business representative on cross functional teams with IT to lead the use, maintenance, and continuous improvement of GLS and Veeva Vault; ensuring labeling systems meet business and functionality requirements.
• Own and support labeling related CAPAs, label complaints investigations, labeling system regression testing, GLS or Printer Qualifications, etc.
• Implement and manage qualification and/or validation of labeling systems and equipment necessary for printing labels, graphics, artwork, etc.
• Responsible for the creation, revision and oversight of labeling system procedures and work instructions.
• Understand UDI labeling requirements, the process for submitting UDI label data elements to government agencies (US, EU, etc) and maintenance and reporting of UDI elements within labeling.
• Serve as mentor for Global labeling personnel and project team members, providing labeling system support, training, continuing education and problem-solving assistance for system users (license holders).
• Apply advanced knowledge, under general guidance, on concepts, principles, and technical capabilities for projects of increased scope and complexity
• Collaborate and coordinate labeling efforts with all Hollister Inc. sites, across time zones, as necessary
• For Veeva Vault only:
• In partnership with IT, maintain licensing requirements for labeling materials in Veeva Vault
• Serve as records champion for approved labeling materials ensuring retirement or replacement of materials aligns to company records management practices
• Run reports on performance of the Veeva process and users
• Work independently with minimal direction

Note:

This is not an exhaustive list of duties or functions and may not comprise of all ‘essential functions’ necessary to perform…