Assistant Quality Assurance Auditor

QUALIFICATIONS

• Bachelor’s degree in related field and 1 years experience in a non-clinical laboratory, preferably with 1 year of QA/QC experience in the pharmaceutical or medical device industry.
• Excellent communication and interpersonal skills.
• In depth knowledge of GLP requirements of the FDA and EPA.
• In rare circumstances, education and/or experience requirements may be decreased or waived if the individual has an extraordinary educational background or uniquely applicable experience or highly specialized knowledge.
• Appropriate quality certification(s) ( SQA RQAP-GLP or ASQ CQA) is a plus.
• A security clearance of an appropriate level may be required after employment.

GENERAL DESCRIPTION

Ensures good laboratory practices (GLP) in the conduct of non-clinical laboratory studies and work performed in support of such studies. Is fully aware of the GLP requirements of the Food and Drug Administration, the Environmental Protection Agency, and IITRI's policies and procedures.

ESSENTIAL JOB DUTIES

• Reviews all study protocols and conducts inspections to ensure that work being performed adheres to GLP, the protocol, and standard operating procedures.
• Audits research reports for non-clinical laboratory studies and works in support of such studies.
• At the conclusion of any audit or inspection notifies research management and other appropriate staff of the findings. Works with staff to develop and implement any needed corrective action. Documents all findings.
• Follows up on all audits and inspections to insure that corrective actions have been implemented.
• Maintains Quality Assurance archives and filing system.
• Enters all studies into the master schedule to ensure accurate and up to date documentation.
• Complies with security procedures in the performance of duties.
• Performs other duties as assigned.