Key Accountabilities:

• Accountable for maintaining training compliance including training seasonal staff
• Execute personnel monitoring within the aseptic processing area using MODA system
• Support additional site and quality functions, including but not limited to:
• Conduct real time review of batch records, logbooks, and other associated GMP documents
• Execute AQL sampling and inspection of finished drug product
• Possesses strong computer skills and familiarity with quality systems such as TrackWise
• Demonstrates ability to work independently and within a team environment
• Assist quality investigations related to deviations and environmental monitoring excursions
• Provide QA oversight of aseptic processing including QA audit program

o Change Control

o SOP creation and revision

o Validation documentation review

o Site Wide Projects

o Trend reporting

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

Minimum Qualifications: