The Pharmaceutical Microbiology LIMS Analyst serves as the subject matter expert responsible for translating pharmaceutical microbiology laboratory processes into validated LabVantage LIMS solutions. This role combines deep knowledge of GMP microbiology testing with hands on experience configuring, validating, and supporting laboratory information management systems in regulated pharmaceutical environments.
The position partners quality control, microbiology, quality assurance, validation, and IT teams to design and implement compliant LIMS workflows supporting sterility, bioburden, endotoxin, environmental monitoring, microbial identification, and other microbiological testing programs.
- Configure and maintain LabVantage LIMS functionality for pharmaceutical microbiology testing.
- Develop and support test templates, specifications, sampling plans, calculations, and approval workflows.
- Translate laboratory and regulatory requirements into system configurations and functional specifications.
- Support system validation activities, including requirements documentation, testing, traceability, and qualification protocols.
- Ensure compliance with GMP, 21 CFR Part 11, data integrity principles, and global pharmacopoeial requirements.
- Collaborate with QC Microbiology, Quality Assurance, Validation, and IT teams to implement new methods and system enhancements.
- Support regulatory inspections, audits, and computer system validation activities.
- Drive the harmonization and standardization of microbiology methods and workflows across laboratories.
- Provide technical guidance, troubleshooting, training, and ongoing support to LabVantage users.
- Configure test methods, specifications, sampling plans, calculations, result-approval workflows, and stability processes in accordance with USP, EP, JP, BP, 21 CFR Part 11, Annex 11, data integrity principles, and good documentation practices.
- Implement LIMS test methods by gathering requirements, developing functional specifications, supporting system validation activities—including IQ, OQ, PQ, or computer software assurance—and ensuring solutions meet regulatory, operational, and business requirements.
- Serve as a key liaison between laboratory personnel and technical teams to standardize and harmonize microbiology processes across the organization while maintaining inspection readiness and regulatory compliance