ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Assist with the generation, maintenance and distribution of compliance/QAU documents.
- Maintain computer database of all SOP and Form revisions.
- Perform duties of backup Archivist.
- Perform audits of protocols, in-life critical phases, raw data, and final reports to assure accuracy and compliance with GLP Regulations and SOPs.
- Participate in Quality Assurance projects.
- Assist with internal or vendor audits.
- Assist with hosting sponsor and agency audits.
- Maintain a safe and healthy work environment that complies with all corporate safety policies and Occupational Safety and Health Administration (OSHA) standards.
- Perform all other related duties as assigned.
- Education: Associates Degree.
- Experience: A minimum of one year, full-time preclinical QA experience. A minimum of one year, pre-clinical medical device QA experience preferred. Demonstrated knowledge of the FDA GLP Regulations. Demonstrated knowledge of MS Office (Word, Excel, PowerPoint, etc.).
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: RQAP/GLP desired.
Other: Consistently demonstrate ability to respond to changing situations in a flexible manner in order to meet current needs such as reprioritizing work as necessary and organizing job function and work area to be able to effectively complete varied assignments within established time frames!