Senior Analyst, Pharmaceutical Microbiology LIMS
About The Position
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.
Requirements
- Bachelor’s or Master’s degree in Microbiology, Biology, Pharmaceutical Sciences, and/or Biotechnology
- 5+ years of experience in a GMP (Good Manufacturing Practices) pharmaceutical laboratory
- Experience with USP, EP, JP, and BP methods; sterility testing; bioburden; endotoxin; environmental monitoring; microbial identification; and method suitability studies.
- Laboratory Information Management System (LIMS) knowledge
- LabVantage LIMS Application
- Test templates
- Specifications
- Sampling plans
- Calculations
- Stability workflows
- Result entry and approvals
- Regulatory knowledge
- USP 71, 61, 62 and 85
- 21 CFR Parts 11, 210, and 211
- Data integrity principles (ALCOA+)
- Good Documentations Practices (GDP)
Nice To Haves
- Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
Responsibilities
- 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.
Benefits
- Medical, dental and vision insurance
- life insurance
- employee assistance programs
- 401(k) with company match (immediate vesting upon enrollment)
- Online training courses
- virtual and classroom development experiences
- tuition reimbursement program
- Paid-time off
- family leave
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What This Job Offers
Job Type
Full-time
Career Level
Senior
