Senior Analyst, Pharmaceutical Microbiology LIMS

📋 Description

• Configure and maintain LabVantage LIMS functionality for pharmaceutical microbiology testing.
• Develop and support test templates, specifications, sampling plans, calculations, and approval
• Translate laboratory and regulatory requirements into system configurations and functional
• Support system validation activities, including requirements documentation, testing, traceability
• Ensure compliance with GMP, 21 CFR Part 11, data integrity principles, and global pharmacopoeial
• Collaborate with QC Microbiology, Quality Assurance, Validation, and IT teams to implement new

🎯 Requirements

• Bachelor’s or Master’s degree in Microbiology, Biology, Pharmaceutical Sciences, and/or
• 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
• Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
• Laboratory Information Management System (LIMS) knowledge: LabVantage LIMS Application, Test
• Regulatory knowledge: USP 71, 61, 62 and 85, 21 CFR Parts 11, 210, and 211, Data integrity

🎁 Benefits

• Medical, dental and vision insurance, life insurance, employee assistance programs
• 401(k) with company match (immediate vesting upon enrollment)
• Professional Growth: Online training courses, virtual and classroom development experiences
• Work-Life Balance: Paid-time off and family leave