Senior Analyst, Pharmaceutical Microbiology LIMS
SGS North America Inc.
Job at a glance
Full-time Compensation: USD 80000 - USD 100000 - yearlyCompany DescriptionWe are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. Job DescriptionThe 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 complianceQualificationsEducation and ExperienceBachelor's or Master's degree in Microbiology, Biology, Pharmaceutical Sciences, and/or Biotechnology5+ years of experience in a GMP (Good Manufacturing Practices) pharmaceutical laboratoryExperience with USP, EP, JP, and BP methods; sterility testing; bioburden; endotoxin; environmental monitoring; microbial identification; and method suitability studies.Knowledge/ Skills/ AbilitiesAbility to manage and coordinate multiple projects in a fast-paced, highly professional environment.Laboratory Information Management System (LIMS) knowledgeLabVantage LIMS ApplicationTest templatesSpecificationsSampling plansCalculationsStability workflowsResult entry and approvalsRegulatory knowledgeUSP 71, 61, 62 and 8521 CFR Parts 11, 210, and 211Data integrity principles (ALCOA+)Good Documentations Practices (GDP)CompensationThe expected salary range for this position is $80,000 - $100,000 annually.
This range represents the minimum and maximum base salary we reasonably expect to pay for this role. Actual compensation within the range will depend on skills, experience, and qualifications.Our BenefitsWe care about your total well-being and will support you with the following subject to your locati