Job description
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
Supervise seasonal staff e.g. day to day work load and time sheet approval
Investigate deviations related to production operations
Prepare validation protocols and reports
Apply risk based decision making to solve complex problems
Act as a delegate to the Manager of QA OTF
Provide leadership to others within and outside of the QA function
Lead projects related to Quality and Production initiatives
MINIMUM QUALIFICATIONS:
- Bachelor of Science Degree
- 5 years of experience in bio-pharmaceutical or pharmaceutical industry
- GMP experience in a QA role
- Flexibility to work shifts as business needs
DESIRABLE QUALIFICATIONS:
- Commercial Packaging experience
- Technical writing skills
- Project management skills
- Operational Excellence / Lean Manufacturing knowledge
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