Description
Job Duties:- Coordinate and conduct internal system audits and external investigative site/vendor audits;
- Create, maintain, and revise departmental Standard Operating Procedures, forms, and templates;
- Coordinate, conduct, and track company-wide Regulatory Training (ICH/GCP, GLP, Medical Device);
- Assist QA Director with departmental overview and development of QA Auditors;
- Coordinate, conduct, track, and resolve company-wide Corrective Action/Preventative Action (CAPA) investigations;
- Develop training materials and applicable tests and guides;
- Work with outside clients/sponsors; and
- Other items as deemed necessary.
Qualifications:
- Bachelor's degree in life sciences or nursing;
- 3 or more years of experience in a QA department in a related industry;
- Knowledge of GCP and/or GLP;
- Past supervisory experience is preferred;
- Independent thinking and planning ability;
- Excellent written and verbal communication skills;
- Exceptional teamwork skills; and
- Ability to work independently.
Travel: Average of 25%
To find out more about Real Staffing please visit www.realstaffing.com