Auditor

FDA Quality and Regulatory Consultants (FDAQRC) is an established, growing consulting firm which specializes in helping Pharmaceutical, Medical Device and Biotech companies. As we continue to grow and lead our field, we are seeking a superstar Auditor to join our corporate team in a newly created full-time position.

If you specialize in both Good Clinical Practice and Pharmacovigilance (GCP/PV) auditing we want to talk to you.

We are headquartered in Austin, Texas; however, this opportunity is remote/home-based anywhere. Travel for business is expected 50-75% of the time.

Please apply if you have at least two (2) years of auditing experience in both GCP and PV at sponsor or CRO organizations.

• A university degree or proven skills, verifiable with references, in a related area
• A minimum of two (2) years of experience, with greater preferred
• Strong command of US GCP and PV regulations, guidance and industry trends
• Auditing certifications by industry organizations (e.g., SQA, ASQ, ISO) preferred
• Excellent written and oral communication skills
• Proficiency in the use of computers for the professional working environment such as: Microsoft Office (e-mail, word processing, spreadsheets)
• Willingness to travel as required, although mostly domestic

We require all employees to work well with all levels of internal management and staff, as well as outside clients and vendors. Sensitivity to confidential matters is required.

Qualified candidates should email their CV. Please place the words GCP/PV Auditor in the subject line.