QA Compliance Specialist III

Job Summary

A company is looking for a QA Compliance Specialist III in Third Party Manufacturing.

Key Responsibilities

• Maintain effective liaison with Quality, Regulatory, Technical, and Supply Chain areas
• Ensure production at TPM sites complies with current good manufacturing practices and specifications
• Review and approve manufacturing directions, investigations, and annual Product Quality Reviews

Required Qualifications

• Bachelor's degree in Engineering or Science
• Six years of experience in Pharmaceutical operations, preferably in Biologic manufacturing
• Knowledge of GMP regulations and standards for pharmaceutical products
• Experience with change notifications and third-party manufacturing
• Familiarity with SAP and LRMS is highly preferred