Regulatory Associate in King of Prussia, PA

Smith Hanley is in search of 2 Regulatory Associates in King of Prussia, PA  Regulatory Associate-  Bachelors degree required, prior QA experience (not necessarily biopharms). GMP compliance issues, assist in the maintenance of GMP Quality Systems within Biopharm CEDD. Interface with document management. This position will have the responsibility to assist the BQA organization in the management of our responsibilities including documentation review, investigation management, metrics management, inspection readiness, and etc.In this role, you will be expected to: be responsible for reporting all serious GMP compliance issues, assist in the maintenance of GMP Quality Systems within Biopharm CEDD, assist with the management of suppliers and third party, review GMP documentation, policies, procedures, etc.  Interface with document management who provide documentation support, tracking of outstanding documents, and related support, assist in hosting inspections and responding to observations, identify inefficient processes and drive continuous improvement.  Regulatory Associate-  Bachelors degree required, prior QA experience (not necessarily biopharms). GMP compliance issues, assist in the maintenance of GMP Quality Systems within Biopharm CEDD. Interface with document management. This position will have the responsibility to assist the BQA organization in the management of our responsibilities including documentation review, investigation management, metrics management, inspection readiness, and etc.In this role, you will be expected to: be responsible for reporting all serious GMP compliance issues, assist in the maintenance of GMP Quality Systems within Biopharm CEDD, assist with the management of suppliers and third party, review GMP documentation, policies, procedures, etc.  Interface with document management who provide documentation support, tracking of outstanding documents, and related support, assist in hosting inspections and responding to observations, identify inefficient processes and drive continuous improvement.Please respond to posting or send your resume in word format via email to nparis@smithhanley.com   Reference Code:3020485 Email:Apply by Email