4 дня назад
Senior Analyst, Pharmaceutical Microbiology LIMS (LabVantage)
80 000 - 100 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Analyst, Pharmaceutical Microbiology LIMS (LabVantage): Translating GMP pharmaceutical microbiology laboratory processes into validated LabVantage LIMS solutions with an accent on compliant workflows for sterility, bioburden, endotoxin, environmental monitoring, and microbial identification. Focus on configuring test methods and approval workflows, supporting IQ/OQ/PQ and computer system validation, and maintaining compliance with 21 CFR Part 11, pharmacopoeial requirements, and data integrity principles.
Location: Various locations in Fairfield, Lincolnshire, NJ, and IL, United States
Salary: USD 80,000–100,000 annually
Company
SGS is a global testing, inspection, and certification company operating a network of offices and laboratories.
What you will do
- Configure and maintain LabVantage LIMS functionality for pharmaceutical microbiology testing.
- Develop test templates, specifications, sampling plans, calculations, stability workflows, and result-approval processes.
- Translate laboratory and regulatory requirements into functional specifications and compliant system configurations.
- Support validation activities, including requirements documentation, testing, traceability, IQ, OQ, PQ, and computer software assurance.
- Partner with QC Microbiology, Quality Assurance, Validation, and IT teams to implement methods and system enhancements.
- Provide troubleshooting, training, technical guidance, audit support, and ongoing assistance to LabVantage users.
Requirements
- Bachelor’s or Master’s degree in Microbiology, Biology, Pharmaceutical Sciences, and/or Biotechnology.
- At least 5 years of experience in a GMP pharmaceutical laboratory.
- Experience with USP, EP, JP, and BP methods, including sterility, bioburden, endotoxin, environmental monitoring, microbial identification, and method suitability studies.
- Experience with LIMS, LabVantage, test templates, specifications, sampling plans, calculations, stability workflows, result entry, and approvals.
- Knowledge of USP 71, 61, 62, and 85; 21 CFR Parts 11, 210, and 211; ALCOA+ data integrity principles; and Good Documentation Practices.
- Work location is in the United States at the listed Fairfield, Lincolnshire, or Illinois locations.
Culture & Benefits
- Medical, dental, and vision insurance.
- Life insurance and employee assistance programs.
- 401(k) with company match and immediate vesting upon enrollment.
- Online and classroom training, tuition reimbursement, and professional development opportunities.
- Paid time off and family leave.
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