Related skills
gxp lims cell-based assays immunoassays qpcr📋 Description
- QC review of data and documentation for regulated studies (GLP/GMP)
- Identify deviations, OOS and OOT in Bioanalytical data
- Issue QC observations and ensure data integrity with staff
- Collect metrics to monitor QC reviews and drive improvements
- Educate and guide staff on GxP best practices
🎯 Requirements
- 2+ years in biotech, pharma, CRO/CMO or similar
- Knowledge of GxP regulations
- Experience with immunoassays, cell-based assays, or qPCR
- Self-motivated, able to work in a fast-paced, multi-project environment
- Independent work style with attention to detail
- Proficiency in LIMS and Quality Management software
🎁 Benefits
- Medical Insurance (HDHP with HSA; PPO)
- Dental Insurance
- Vision Insurance
- Flexible Spending Account (medical; dependent care)
- Short/Long-Term Disability & Life Insurance
- 401k with Employer Match
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