We are seeking a detail-oriented LIMS Administrator focused on validation to ensure the integrity and regulatory compliance of our LIMS. The role involves collaborating with various departments to validate and optimize the LIMS for effective data validation processes.
Key Responsibilities:
- System Validation:
- Lead LIMS validation to meet industry and regulatory standards.
- Develop and execute IQ, OQ, and PQ validation protocols.
- Document and maintain validation plans, test scripts, and reports.
- System Administration:
- Configure, maintain, and upgrade LIMS software and hardware.
- Ensure system availability, performance, and security.
- Perform regular system backups and recovery.
- Data Management:
- Oversee data entry, storage, retrieval, and reporting within the LIMS.
- Ensure data integrity and compliance with regulatory standards.
- Implement and enforce data validation protocols.
- Collaboration and Quality Assurance:
- Collaborate with lab staff and other departments for LIMS integration.
- Monitor system performance and conduct regular audits.
- Develop and implement LIMS-related SOPs.
Qualifications:
- 5 years of experience with LIMS administration and validation.
- Proficiency with LIMS software (e.g., LabWare).
- Strong understanding of laboratory workflows and data management.
Preferred Skills:
- SQL and database management experience.
- SAS
- Knowledge of regulatory requirements (e.g., FDA, GLP, ISO).
- Familiarity with scripting languages (e.g., Python, Perl).
