| Job Description: |
This role is critical in transitioning our GxP test method documentation from paper-based records to a digital platform. The analyst will focus on the development, configuration, and site acceptance of test method templates, with potential involvement in other critical digital systems like LIMS, ERP, and equipment integration.
Key Responsibilities:
Test Method Template Development: Translate existing paper-based site analytical test methods into structured, configurable digital templates within the new web-based application. Engage with laboratory SMEs during development cycles.
System Configuration: Configure test method templates to accurately reflect the sequential steps, required data inputs, calculations, and approval workflows of the site's analytical testing processes, ensuring GxP compliance.
Testing and Validation: Execute rigorous testing (e.g., User Acceptance Testing - UAT) for all configured templates to ensure functionality, data integrity, and adherence to regulatory requirements.
Site Acceptance: Collaborate with Quality Control (QC) teams to finalize and gain formal site acceptance for all deployed method templates.
Documentation: Maintain comprehensive records of configuration settings, testing results, and validation documentation.
Cross-System Support (As Needed): Provide support for LIMS (Laboratory Information Management System), ERP (Enterprise Resource Planning) master data build, configuration, and testing activities, and equipment integration projects.
Stakeholder Communication: Serve as a key liaison between the local site analytical lab users, IT teams, and the global enterprise application team.
Required Experience & Skills:
Analytical Laboratory Experience: Minimum of 2 years of hands-on experience working in an analytical testing lab environment (e.g., QC, R&D) in a regulated industry (e.g., pharmaceutical, biotech, cell and gene therapy).
Digital System Implementation: Proven experience supporting the implementation or upgrade of a digital system (e.g., LIMS, ELN, QMS) in a GxP environment.
GxP Knowledge: Strong working knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), particularly as they relate to data integrity and documentation within a regulated manufacturing setting.
Attention to Detail: Exceptional precision in translating complex technical documentation into system configurations.
Software Proficiency: Experience with configuring web-based enterprise applications or database-driven systems.
Preferred Experience & Skills:
Experience with Cell and Gene Therapy manufacturing or testing processes
Familiarity with LIMS and/or ERP systems and/or equipment integration
Experience with testing protocols and execution within a validated system lifecycle
Ability to rapidly onboard and perform work tasks semi-independently
Proven ability to meet on-time delivery of work assignments
Excellent communication abilities and keen awareness to spot project risks and identify escalations to senior management |
