Data Reviewer (QC Specialist)

📋 Description

• QC review of data and documentation from Bioanalytical Operations for regulated studies (GLP/GMP).
• Identify deviations, OOS and OOT in Bioanalytical Operations data.
• Issue QC observations and work with scientific staff to ensure data integrity.
• Collect metrics to monitor QC reviews and identify process improvements.
• Educate and influence scientific staff on GxP compliance best practices.

🎯 Requirements

• Bachelor's in biological science with 2-10 years in biotech/pharma/CRO/CMO; or MS/PhD.
• Knowledge of GxP regulations.
• 2-4 years’ data review experience in a GxP setting.
• Experience with bioanalytical methods (immunoassays, cell-based assays, or qPCR).
• Self-motivated and able to work in fast-paced, multi-project environment.
• Independent work style with attention to detail and minimal oversight.
• Technical data review following GxP regulations and scientific principles.
• Strong communication and collaboration skills.
• Confidently share observations respectfully.
• Proficiency with LIMS and quality management software.

🎁 Benefits

• Medical, dental, and vision insurance.
• FSA options for medical and dependent care.
• Disability and life insurance.
• Paid time off, parental leave, and holidays.
• 401k with employer matching and employee referral program.