Sr Labeling Systems Specialist

We Make Life More Rewarding and Dignified

Location: Libertyville
Department: Regulatory

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 VeevaVault; 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 VeevaVault only:
• In partnership with IT, maintain licensing requirements for labeling materials in VeevaVault
• 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 this role. (for ADA purposes)

Requirements:

• Number of Overall Years Necessary: 5-8
• Medical device or other health industry labeling systems experience preferred
• Global labeling system software preferred
• Printing systems and substrates preferred
• Bachelor degree in computer science or related industry is required
• Industry certifications desirable

Specialized Skills/Technical Knowledge:

• Effective communication skills to provide direction and ensure the completion of Global Labeling systems and initiatives.
• Strong understanding of how labeling systems communicate with other business systems.
• Ability to build and strengthen relationships with other areas of the organization (i.e. IT, Regulatory Affairs, Manufacturing, etc) across different locations including vendors (external suppliers, contract manufacturers, etc).
• Detail oriented with excellent organizational skills and ability to make informed decisions and work well with others.
• Exposure to working knowledge of US, EU and ROW labeling requirements for medical devices as well as overall FDA, MDR and UDI regulations.
• Clear, concise and effective oral and written communication skills are required.
• Working knowledge of Hollister product, as well as Hollister labeling practices, procedures and systems;
• Solid, functional understanding of departments' needs, capabilities and system interfaces.
• Software experience with Qumas, SAP, PXSmartPrint, Loftware, Veeva, Microscan, etc is desired
• Knowledge of printable packaging and labeling substrates and printing systems
• Experience with automated platforms for routing and approval of labeling materials (ex: Veeva PromoMats, etc.)
• Problem-solving skills with ability to analyze all aspects of a situation, identify potential solutions and implement the solution in a timely manner.
• Experience with labeling and technical data entry
• Adaptability
• Effective technical Writing
• Fluency in English

Essential Functions of the Role:

• Use of computer and accessories (monitor, keyboard, mouse) and label printers

#LI-Hybrid

Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.

• The anticipated base pay range for this position is $85,000 - $121,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
• This position is also eligible to participate in the Hollister Corporate Bonus Plan.
• The Company's health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
• The Company's 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe harbor" matching contributions.
• The Company's paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
• The Company's additional benefits include: education assistance and adoption assistance benefit programs.

About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement
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.

Job Req ID: 35570