QA Auditor

Responsibilities:

Performs internal and external cGMP audits ensuring compliance with all Food and Drug Administration,EMEA,and Biological Licensing Agreements guidelines for regulatory standards, as well as company policies/procedures. Develops and coordinates Quality Assurance Standard Operating Procedures to ensure compliance with the Food and Drug Administration and global regulatory organizations. Maintains quality database of observations for quality analysis and assessment and identifies compliance risk. Conducts internal document reviews and takes corrective action. Performs technical document review and other good manufacturing practices activities in support of commercial as well as clinical development programs. Supports quality assurance staff on good manufacturing practice requirements of drug product manufacture. Provides audit reports to clinical management

 

 

Qualifications:

3-5 years direct GMP auditing experience, preferably in the field of Biotech. An educational background of BS or equivalent.