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Position Summary :
This position is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in-process and stability test data.
This position is also responsible for the review and approval of method qualifications and validations. Another responsibility is the review and approval of laboratory investigation and deviations associated with the laboratories.
Position Responsibilities :
Performs compliance review on the following records : release, in-process, and stability data
Responsible for the review and approval of method qualifications and validations
Responsible for the review and approval of deviations and laboratory investigations
Minimum Requirements :
For Specialist II : BS and 11+ years of experience or MS and 8+ years of experience in a GMP regulated environment within biopharmaceuticals or equivalent
For Senior Specialist : BS and 14+ years of experience or MS and 11+ years of experience in a GMP regulated environment within biopharmaceuticals or equivalent
Experience in QA review of analytical data (release, in-process, and stability)
Experience in reviewing method qualifications / validations and the review and approval of laboratory investigations and deviations
Knowledge of USP, EU and JP cGMP guidelines
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