The Quality Assurance Associate supports the maintenance of quality systems and processes at
the organization.  He/she is responsible for supporting QA systems to assure cGMP compliance
for all relevant operations carried out within and for IPM including activities related to
preclinical and clinical supplies and potentially commercial production.   

To perform this job successfully, an individual must be able to perform each essential duty
satisfactorily:  

� Implement specifications, coordinate testing, and release incoming ingredients

� Responsible for the review and approval of IOP Qualification, Validation Protocols,
Specifications, and Master Production Records (MPR)

� Assist in the resolution and approval of deviations/investigations

� Implement and track CAPA issues

� Approve randomization codes, labels and MPRs for clinical packaging

� Review and release clinical batches 

� Organize, track and file QA documents

� Review stability protocols and testing

� Review cleaning logs, temperature charts and other supporting batch record documentation

� Contribute to the development of Standard Operating Procedures (SOPs)

� Implement new and revised SOPs

� Provide GMP training for Clinical Trial Materials (CTM) employees

� Organize, track and file all controlled documents related to the CTM facility

� Assist in quality functions involved in contract manufacturing