One of our Global Medical Device partners is seeking a QA Auditor to join their team! This is a great opportunity for individuals who are interested in transitioning from the bench to a more documentation focused role.
Principal Duties and Responsibilities
Evaluate data and/or lab work to assess compliance with quality system regulations (ISO, GMP, and GLP) and SOPs.
Review records for accuracy, consistency, and compliance.
Participate in audits of facilities, suppliers and agencies.
Perform periodic audits of internal operations to assess internal performance and detect quality problems.
Determine source of quality problems and makes recommendations for improvements.
Assure corrective action is taken through follow up activities.
Assist in design of test validation programs and check sample evaluations.
Assists in lab qualification activities.
Maintain QA training manual to reflect current practices.
Approve client submitted test specifications in Master Control.
Qualifications and Skills
Bachelor’s degree in a scientific discipline
Requires 1-2 years experience in GLP or GMP regulated environment.