Related skills
gcp gmp glp csv lims📋 Description
- Author and review analytical methods, protocols, reports, and SOPs.
- Maintain analytical instrumentation and computer control systems.
- Onboard and implement LabVantage for LIMS/ELN/inventory.
- Improve technical operation workflows and project outcomes.
- Support lab operations – inventory, sample management, docs.
- Ensure adherence to GMP/GLP/GCP/GDP where required.
🎯 Requirements
- Master’s in biological sciences or related field; 2+ years in biotech.
- Experience in project management.
- Experience in Continuous Improvement and Lean Six Sigma.
- Experience drafting protocols, methods, reports, and SOPs.
- Experience in system validation, CSV, onboarding/implementation.
- Experience performing root cause analysis and CAPA.
- Familiarity with ICH guidelines and FDA regulations.
- GxP knowledge.
🎁 Benefits
- Experience in BlueMountain.
- Experience in QUMAS.
- Experience in Veeva.
- Experience in Smartsheet, Notion, and/or Monday.
- Experience in change control, deviation, laboratory investigation, and/or other quality records.
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