Evaluates lab work for compliance with quality system regulations (ISO, GMP, GLP) and standard operating procedures. Participates in audits of NAMSA suppliers and performs periodic audits of internal operations. Assures the quality and integrity of data through In-life inspections and final report audits. Communicates concerns and makes recommendations for improvement. May assist in lab qualification activities. Must establish follow up activities to assure corrective action has been taken. No direct client contact.
Education
Requires a Bachelors degree in a scientific discipline.
Experience
Requires 1-2 years of experience working in a QA or laboratory role.
Requirements
Must have knowledge of GMP/GLP regulations and familiarity with a broad base of scientific applications sufficient to support understanding of NAMSA's test methods or processes and sound risk assessment in these areas; awareness of issues of control for scientific bias; metric measurements, use of biostatistics, statistical process control techniques, validation of test methods and fundamentals of technical writing. Sound judgment concerning scientific and regulatory issues, accuracy and attention to detail, meticulous documentation practices, excellent organizational and communication skills (written and oral), effective problem solving capabilities, initiative, and ability to work with minimal supervision.
For more information or to apply for this position, please contact hr@namsa.com.
