QC Reviewer

Job Summary

A company is looking for a QC Reviewer to support regulatory submissions and ensure data accuracy.

Key Responsibilities

• Interact with multidisciplinary teams to ensure timely delivery of documents for regulatory filings
• Verify data consistency between regulatory submissions and source documents, addressing discrepancies as needed
• Evaluate laboratory data for compliance and prepare QC statements regarding analytical data deficiencies

Required Qualifications

• Associate or Bachelor's Degree in Science or Engineering discipline
• 2+ years of relevant experience or a Master's degree with related experience
• Knowledge of Good Manufacturing Practices and Good Documentation Practices in a pharmaceutical environment
• Proficiency in MS Word, Excel, and PowerPoint
• Ability to work in diverse and potentially hazardous environments