Formulated to Care

For more than 75 years, GOJO, Makers of PURELL® has been powered by people who are energized by helping the world experience greater health and well-being.

The positive impact of our PURELL® hand and surface hygiene solutions is driven by our global community of highly collaborative and talented team members who love to learn, innovate, care for each other, and deliver our Purpose of Saving Lives and Making Life Better.

Role Objective

This role ensures the system meets the laboratory’s needs, maintains data integrity and security, and facilitates efficient workflow automation in an FDA regulated environment. As a Title 21 Part 11 application, the LIMS Administrator is responsible for configuration, monitoring, maintenance, and administrative tasks for LabWare LIMS.

Essential Functions and Responsibilities

Ensures data integrity and security within LIMS, including regular audits and compliance with regulatory standards (Code of Federal Regulations, Title 21 (Food and Drugs).

• Develops and maintains integrations between LIMS and other laboratory instruments, systems, and databases to facilitate secure data exchange and workflow automation.
• Maintains comprehensive documentation of system configurations (SRG), standard operating procedures (SOPs), and user guides.
• Ensures LIMS complies with all relevant regulatory requirements throughout GOJO distribution regions and industry standards.
• Develops (with assistance), conducts, or verifies hardware and software qualifications necessary for LIMS. Author, verify and review test scripts and validation protocols as identified.
• Documents review of risk-assessment on software and module update options for LIMS application.
• Initiates, reviews, and implements change controls following approved change management procedures.
• Documents, tests changes, and supports other LIMS SMEs with similar tasks.
• Modifies subroutines and other programming structures within LIMS.
• Participates in Code Review and strategic development of LIMS objects.
• Utilizes configuration package workflow for static data management following approved procedures.
• Coordinates static data updates with documentation effective dates with LIMS SMEs.
• Supports enterprise need for annual and ad hoc reporting and audits,
• Modifies reports using Crystal Reports (and/or other reporting software).
• Performs daily maintenance tasks in LIMS, checking error logs, reviewing user account status, trending issues.
• Maintains static data objects with LIMS following approved procedures.
• Reviews statistical testing of data to verify validity, determine trends, and initiate corrective actions as appropriate.
• Stays current with all role based training requirements.
• Collaborates with laboratory staff and GOJO SMEs to identify areas for system improvement and implement enhancements.
• Continuously improves work processes, productivity, and accuracy of LIMS Administrators.
• Assists to provide troubleshooting support to interfaced business systems (SAP, Empower, MES relative to LIMS interfaces
• Assists in defining and testing LIMS requirements in SAP
• Provides support and troubleshooting for LIMS users
• Works with IT counterparts to ensure functionality 24/7
• Occasionally acts as point of contact for Labware support calls
• Maintains a working knowledge of regulatory requirements for electronic records and electronic signatures throughout GOJO product distribution regions.
• Keeps abreast of the LabWare Support Site, version continuity, white papers and future topics.

#LI-Remote

Education and Experience

• BA, BS degree in Computer Science, Database Management, Scientific or other Engineering discipline preferred with minimum one (1) year of experience in LIMS role in an FDA regulated environment
• In lieu of degree, minimum five (5) years' experience as a LIMS SME or Admin
• Proficient in statistical analysis tools, network architectures, programming tools and processes
• Familiarity with Oracle, SQL required
• Experience with system integration issues such as SAP EWM and PASX environments preferred
• Relevant certifications in LabWare LIMS administration or related fields are a plus

Supervision/Coordination

• Does not supervise other team members
• Coordinates gathering and dissemination of information internally
• Provides instruction to LIMS SMEs for compliance with written procedures relative to LIMS operations

Travel Requirements