Duties Conduct work as identified on the audit activity table 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.
Requirements A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience) 2 years in regulatory environment (experience in GXP roles) Knowledge of and ability to interpret and apply (applicable) regulations in order to monitor compliance 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 Experience may be substituted for education.