Quality Assurance monitor - Toxikon corporation

Position Description

In this quality assurance role, the appropriate candidate will be responsible for the implementation, functioning, and monitoring of quality assurance activities in the InVitro and InVivo toxicology division. This includes monitoring biological and chemical studies, and creating reports in conformance with GLP practices. He or she will review both GLP and non-GLP reports for accuracy with reference to protocols, Quality Assurance Standards, Standard Operational Procedures, laboratory precision and accuracy limits, as well as reviewing all protocols for compliance and accuracy.

Other quality assurance responsibilities include maintaining equipment performance, calibration records and preventative maintenance logs. Included duties are performing system and phase audits according to GLP and ISO guidelines, as well as all other activities required from quality assurance.

A bachelors degree in life sciences is required. Candidates should also have at least two years experience in an FDA regulated environment, with basic knowledge of study design and review practices. Must have strong documentation and coordination practices, including responsibilities for laboratory quality system auditing, phase auditing, and data review. Toxikon is seeking a strong detail oriented person who enjoys high volume work on computers. GMP experience is a plus.

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