Pharmaceutical Labeling Analyst
The Fountain Group, California, Missouri, United States, 65018
Overview
Senior BSA Label Design & Implementation Contractor with deep expertise in Bartender label design software and Visual Basic (VB) scripting. The ideal candidate will support end to end label lifecycle activities—including design, configuration, testing, validation, and deployment—within a GxP-regulated biopharma, biotech, or cell therapy environment. This role requires strong collaboration with IT, Supply Chain, Quality, Manufacturing, and R&D or QC Lab teams to ensure compliant, reliable, and scalable labeling solutions.
Work with the company commercial and clinical supply chain organizations, regulatory affairs, manufacturing and quality stakeholders to support requirements gathering, prototyping, and label design.
Work with cross functional IT teams on the implementation, testing, deployment, and support of labels.
Must be experienced working in GxP environment.
Must have strong collaboration and clear communication skills with ability to present technical concepts to non-technical audiences.
Must be comfortable to work with ambiguity, engage and align cross-functional stakeholders and delivery partners.
Should have experience leading workshops and meetings, bringing people together, and ensuring structured process-driven approach to projects and support.
Will be a key point of contact for labeling ensuring projects and dependencies are tracked, risks escalated and mitigation strategies proposed in a timely manner.
Essential Duties
Label Design & Development: Design, develop, configure, and optimize labels using Bartender, including advanced templates, dynamic data handling, automation, and printing logic.
Label Lifecycle Management: Drive the full label lifecycle: requirement gathering, design, configuration, testing, validation, production deployment, and support.
System & Process Integration: Collaborate with Supply Chain, Regulatory, Quality, Manufacturing, and IT teams to ensure alignment of label workflows with end to end business processes.
Testing, Validation & Compliance: Develop and execute test plans for label functionality, integrations, and printing performance.
Support & Continuous Improvement: Provide hands-on support during transitions, system upgrades, and site enablement projects.
Required Qualifications
Expert-level proficiency with Bartender, including design, automation, and server components.
Strong Visual Basic / VBScript skills applied to label automation and dynamic behavior.
Strong troubleshooting skills in complex labeling ecosystems involving MES, ERP, and printing hardware.
Experience in biotech, pharma, or cell therapy supply chain, with familiarity in materials management, batch/lot control, serialization, and regulated operations.
Highly Desirable Qualifications
Experience implementing or supporting laboratory instruments in QC labs or research environments (e.g., label printers, scanners, nucleocounters, cytometry instruments, and similar).
Experience working in IT site support, particularly in environments managing lab, manufacturing, or supply chain systems.
Experience working with Robar labeling software (configuration, troubleshooting, integration).
Experience with EBS (Oracle E Business Suite) for label data sourcing or workflow integration.
Preferred Qualifications
Prior involvement in labeling system standardization, migration, or transformation initiatives.
Familiarity with validation documentation (URS, FRS, IQ/OQ/PQ).
Experience supporting enterprise label architecture involving MES (e.g., Client-X), ERP, or middleware integrations.
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Work with the company commercial and clinical supply chain organizations, regulatory affairs, manufacturing and quality stakeholders to support requirements gathering, prototyping, and label design.
Work with cross functional IT teams on the implementation, testing, deployment, and support of labels.
Must be experienced working in GxP environment.
Must have strong collaboration and clear communication skills with ability to present technical concepts to non-technical audiences.
Must be comfortable to work with ambiguity, engage and align cross-functional stakeholders and delivery partners.
Should have experience leading workshops and meetings, bringing people together, and ensuring structured process-driven approach to projects and support.
Will be a key point of contact for labeling ensuring projects and dependencies are tracked, risks escalated and mitigation strategies proposed in a timely manner.
Essential Duties
Label Design & Development: Design, develop, configure, and optimize labels using Bartender, including advanced templates, dynamic data handling, automation, and printing logic.
Label Lifecycle Management: Drive the full label lifecycle: requirement gathering, design, configuration, testing, validation, production deployment, and support.
System & Process Integration: Collaborate with Supply Chain, Regulatory, Quality, Manufacturing, and IT teams to ensure alignment of label workflows with end to end business processes.
Testing, Validation & Compliance: Develop and execute test plans for label functionality, integrations, and printing performance.
Support & Continuous Improvement: Provide hands-on support during transitions, system upgrades, and site enablement projects.
Required Qualifications
Expert-level proficiency with Bartender, including design, automation, and server components.
Strong Visual Basic / VBScript skills applied to label automation and dynamic behavior.
Strong troubleshooting skills in complex labeling ecosystems involving MES, ERP, and printing hardware.
Experience in biotech, pharma, or cell therapy supply chain, with familiarity in materials management, batch/lot control, serialization, and regulated operations.
Highly Desirable Qualifications
Experience implementing or supporting laboratory instruments in QC labs or research environments (e.g., label printers, scanners, nucleocounters, cytometry instruments, and similar).
Experience working in IT site support, particularly in environments managing lab, manufacturing, or supply chain systems.
Experience working with Robar labeling software (configuration, troubleshooting, integration).
Experience with EBS (Oracle E Business Suite) for label data sourcing or workflow integration.
Preferred Qualifications
Prior involvement in labeling system standardization, migration, or transformation initiatives.
Familiarity with validation documentation (URS, FRS, IQ/OQ/PQ).
Experience supporting enterprise label architecture involving MES (e.g., Client-X), ERP, or middleware integrations.
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