Job Description
We are currently looking to fill a QA Investigation Specialist position with our Bulk Drug Substance Manufacturing Quality Assurance team. This position performs all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing operations.
In this role, a typical day might include the following:
+ Independently investigating non conformances and preventing reoccurrences in support of manufacturing operations
+ Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances
+ Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
+ Communicating findings and recommendations at group meetings
+ Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
+ Reviewing, editing, and revising controlled...
In this role, a typical day might include the following:
+ Independently investigating non conformances and preventing reoccurrences in support of manufacturing operations
+ Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances
+ Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
+ Communicating findings and recommendations at group meetings
+ Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
+ Reviewing, editing, and revising controlled...