Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample) and review audit responses for completeness
Support 'business partner' /liaison meetings representing QA function with operations
Report on relevant quality metrics (for single topics/departments) and highlight trends
Adhere to required timeline on assigned activities
Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
Other duties as assigned by management.
Requirements
Min.
2 years in regulatory environment
A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
Experience may be substituted for education.
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
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