Job Title: Quality Assurance Associate
Date Posted: 05-05-2008
Job Location: Pennsylvania-Philadelphia
Job Type: Full Time
Education Level: Bachelors Degree
Work Experience: 2+ to 5 Years
Job Shift: First Shift
Yearly Salary:30K-50K
Company Name: International Partnership For
Contact Information: Freda   Green (fgreen@ipm-microbicides.org)
Job Description:
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
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