QA Specialist - Formulation & Fill OTF Job at AstraZeneca
Key Accountabilities:
Provide QA oversight of aseptic processing including QA audit program
Execute personnel monitoring within the aseptic processing area using MODA system
Execute AQL sampling and inspection of finished drug product
Conduct real time review of batch records, logbooks, and other associated GMP documents
Assist quality investigations related to deviations and environmental monitoring excursions
Accountable for maintaining training compliance including training seasonal staff
Demonstrates ability to work independently and within a team environment
Possesses strong computer skills and familiarity with quality systems such as TrackWise
Support additional site and quality functions, including but not limited to:
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:
- Bachelor of Science Degree
- 3 years of experience in biopharmaceutical or pharmaceutical industry
- GMP experience in a QA role
Desirable Qualifications:
- High attention to detail and quality of work
- Flexibility to work shifts as business needs
- Strong organizational skills
- Microsoft Office knowledge
- Aseptic Processing experience
- Commercial Packaging experience
- Clinical Filling and Packaging experience
- Technical writing skills
- Project management skills
- Operational Excellence / Lean Manufacturing knowledge
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