Batch Record Specialist

Responsibilities

• Review and verify executed batch records of APIs, drug products, primary and secondary labeling and packaging
• Review and verify analytical data and assess quality control results against acceptable limits
• Ensure compliance with applicable SOPs and regulatory regulations
• Communicate with CMOs regarding missing documentation and error corrections
• Archive batch documentation in eQMS (e.g., Veeva)
• Report all variances, errors, and deviations to supervisor
• Collaborate on complaint and nonconformance reports
• Write and implement SOPs and work instructions for QA processes
• Support inspection readiness

Requirements

• Bachelor’s degree in health, life sciences, or related field
• Minimum 3 years of experience in QA, commercial pharmaceutical drug manufacturing, and GMP
• Working knowledge of FDA, EU regulatory requirements, GxP, and ICH standards
• Experience supporting regulatory inspections and interacting with health authorities
• Strong technical and analytical skills with advanced MS Office knowledge
• Excellent written and verbal communication skills

About the Company

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications.