Location: Home-based for Auditor & Sr. Auditor
Location: Cincinnati, Minneapolis, Dallas for Manager and above
Email: resume@bpsearches.com
Description
Bio-Pharma Searches, Inc. is working closely with a rapidly growing global, full-service Contract Research Organization to fill the role of QA Auditor. The QA Auditor will be responsible for both internal and external audits, as well as coordinating, conducting, and tracking company-wide GCP training and CAPA investigations. This Auditor will also ensure compliance to Standard Operating Procedures and maintain good time management skills. In addition, the auditor will assist in the creation and maintenance of departmental forms, templates, and Standard Operating Procedures, and will also develop applicable training materials, tests and guides. This role is highly visible to our sponsors and internal clients; therefore, the QA Auditor must have exceptional communication skill as well as a highly professional demeanor.
If you are ready to make a difference, you must be able to accomplish these tasks:
- Coordinate and conduct internal system audits and external investigative site/vendor audits;
- Create, maintain, and revise departmental standard operating procedures, forms, and templates;
- Host audits by sponsors and regulatory inspectors;
- Coordinate, conduct, and track company-wide regulatory training (ICH/GCP and medical device);
- 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;
- 2-5 years of experience in a QA department in a related industry;
- Experience conducting audits of vendors and investigative sites
- Experience hosting regulatory authorities and interacting with sponsor/client representatives;
- Independent thinking and planning ability;
- Knowledge and application of GCP is required;
- Medical Device and or Phase 1 experience is a plus;
- Ability to travel up to 50% of time;
- Excellent written and verbal communication skills;
- Exceptional teamwork skills; and
- Ability to work independently.
Travel Requirements: Approximately two audits per month.