Primary Responsibilities and Job Functions:

• The LIMS Administrator is responsible for developing, leading, organizing and managing the LabVantage LIMS System in a GXP environment for the QC Laboratories at ProKidney.
• Interact with quality assurance, IT, and QC to ensure that data flows are compliant within the LIMS system.
• Ensure seamless functional integration with ancillary software systems (e.g., COC/COI, ERP).
• Maintaining and developing a robust LIMS system in a GxP environment with the other LIMS functional roles and LIMS super users.
• Provide 1st/2nd level support for resolving LIMS problems in close collaboration with the IT Helpdesk and LabVantage.
• Improve ProKidney QC operational performance by bringing manual workflows into LIMS and bridging LIMS to other lab management systems and equipment.
• Ability to update specifications and introduce product specifications into LabVantage LIMS.
• Ability to handle all LIMS aspects from QC Microbiology to QC Analytical data.
• Write and maintain documentation for customizations, including code repositories, user manuals, validation documentation, and training materials.
• Deliver to Plan: Integrate the LIMS with other laboratory instruments, software systems, and databases to streamline data transfer and analysis.
• Collaborate with IT staff to coordinate system upgrades, patches, and migrations while minimizing disruptions to laboratory operations.
• Provide training sessions and workshops for end-users to ensure they can effectively utilize the LIMS system.
• Able to clearly communicate problems and observations with management from QC and other departments.

Secondary Responsibilities and Functions:

• Maintain positive working relations with internal/external stakeholders and users.
• Ensure full compliance with cGMP and Quality system requirements for all activities. Responsible for overall regulatory inspection readiness and compliance with quality requirements.
• Implement data backup and disaster recovery procedures to protect critical laboratory data.
• Excellent verbal and written communication skills.
• Ensure that the Quality Control labs computer systems /programs are properly maintained and in GxP compliance.
• Maintain individual training plans and ensure the QC team and other users remain complaint and up to date with training requirements.
• Perform other duties as assigned.

Minimum Requirements:

• Bachelor’s degree in Computer Science, Information Technology, Laboratory Science, or related field. Master’s degree preferred
• General proficiency and experience working in a GxP lab environment required.
• Proven experience (5+ years) working with LIMS administration, configuration, and development. Experience with LabVantage is a plus.
• Experience with biotherapeutic or cell therapy product development is a plus.
• Experience with regulatory (e.g., IND/BLA) filings and GMP inspections is a plus.   
• Proficiency in programming languages such as Java, Python, and JavaScript with experience in web development.
• Must have a knowledge of cGMP facilities and cGMP requirements.
• Computer software skills, organization, record keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills are a plus.
• Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
• Ability to exercise judgment within defined procedures and practices to determine appropriate action.
• Detail-oriented with strong analytical and problem-solving skills
• Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders.
• Proven logic and decision-making abilities, critical thinking skills.
• Expected to keep up to date on regulatory changes for data integrity, US FDA 21 CFR Part 11 and EU Annex 11