Summary: Responsible for performing audits and inspections of facilities, study activities and reports, and for assisting the quality systems department in maintaining FDA Good Laboratory Practice (GLP) and ISO17025 Quality Systems. Uses knowledge of facility and management standard operating procedures (SOPs), GLP and ISO17025 requirements and their applications to the preclinical environment to perform audits and inspections to confirm SOPs, policies, regulations and protocols are being adhered to. Maintains quality records for both the department and the company, and is involved in department activities such as ISO internal audits, Corrective Action/Preventative Action Program, and maintaining the Master schedule.
Duties and Responsibilities include the following. Other duties may be assigned.
1. Performs and documents critical phase audit activities for GLP compliant Studies.
2. Performs and documents audits of final study director and principle investigator reports.
3. Prepares and signs quality assurance statements as required to be included in study
4. Performs and documents audit activities to support ISO17025 internal audit requirements.
5. Performs inspections of internal facilities and of subcontractor's facilities and procedures for
GLP and ISO17025 compliance.
6. Reviews protocols and amendments for GLP compliance, accuracy and compliance with US
and international testing guidelines.
7. Provides technical guidance to study directors and management for maintaining GLP
compliance of assigned studies, departments or processes.
8. Assists in the development and review of standard operating procedures and associated
9. Assists with management of Master Schedule, internal audit schedule, CAPA program, and
10. Schedules and tracks quality assurance audits, inspections and findings. Assists with
coordinating and scheduling departmental activities.
11. Maintains written and signed records of auditing activities and submits written reports to
management and study director.
12. Maintains copies of current protocols and amendments for assigned studies.
- Bachelor degree, or Associates degree with relevant experience is preferred.
- Minimum of one year GLP auditing experience in a preclinical environment with a medical device focus.
- Working knowledge of GLP regulations and ISO17025, and the ability to interpret and apply these to daily work.
- Working knowledge of laboratory procedures, scientific testing standards, good
documentation practices and concepts regarding validation and qualification.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.