Auditor

POSITION PURPOSE:

Responsible for performing all duties associated with the conduct of internal audits at IBR collection centers, corporate operations, and/or vendor/suppliers to measure compliance with International BioResources' SOPs, OSHA, CLIA, iQPP, FDA regulations, customer specifications, German Health Authority regulations, and any other local or state regulatory body as applicable.  The QA audit may be a general overview, pre-licensing audit, follow-up or focused assessment or CAPA effectivity check.  Responsible for facilitating/tracking corrective and preventive actions.  Maintains systems/processes for early identification/detection of issues leading to non-compliance with current Good Manufacturing Practices and Quality Sysem Requirements.  Provide information to regional and corporate management in a manner that will assist to ensure an optimal level of compliance is established and sustained within the supply chain.

 

ADDITIONAL DUTEIS AND RESPONSIBILITES:Train employees as necessary on audit procedures.Assist Director of Corporate QA and Senior Management as needed.

 

EDUCATION and/or EXPERIENCE:

Undergraduate degree in one of the allied sciences (chemistry, biology, medical technology).  Minimum three (3) years experience in biologics / drug manufacturing or FDA regulated laboratory facility.  Relevant auditing experience (at least 2 years) may be substituted for degree requirement, but at least 2 years of college required.  Previous experience should demonstrate expertise in cGMPs and FDA regulations, as well as an understanding of quality control principles and QA audit functions.  ASQ Auditor certification preferred.

 

**Must be able to travel 75% to 100% of the time as required.

 

Make the decision to expand your career with International BioResources!

 Please send all resumes to Jill Bernard at jbernard@ibior.com