Essential Job Duties:
-Conduct internal/external audit, host sponsor audit with guidance from management and review audit responses for completeness
-Support 'business partner' /liaison meetings representing QA function with operations (local)
-Report on relevant quality metrics (for single topics/departments) and highlight trends
-Adhere to required timeline on assigned activities
-Peer Review QA SOP's
-Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated
in applicable controlled documents, are followed
-Other duties as assigned by management.
-A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science
-Experience may be substituted for education.
-2 years in regulatory environment (experience in GXP roles)
-Knowledge of and ability to interpret and apply (applicable) regulations in order to monitor
-Ability to interpret data and identify quality critical problems
-Able to convey regulatory expectations
-Adaptability to an ever changing work environment
-Ability to 'challenge' processes - not just accept status quo and make suggestions to improve
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