Senior Quality Assurance Specialist

Job Summary

A company is looking for a Quality Assurance Specialist-Senior.

Key Responsibilities

• Review stability reports, evaluate data, and manage associated records
• Approve and review documentation related to CMO batch production and assess batch records
• Participate in continuous improvement initiatives and quality system enhancements

Qualifications

• Bachelor's degree in a scientific discipline required
• Minimum 5 years of experience in Quality Assurance roles with increasing responsibility
• Experience working with Quality Systems (deviations, change controls, CAPAs, document management)
• In-depth knowledge of cGMP requirements, specifically 21 CFR Parts 210 and 211
• Experience with sterile injectable pharmaceuticals preferred