Senior Quality Assurance Auditor

We are seeking a talented, highly motivated individual who will be responsible for assisting in the management of overall quality and compliance by performing internal and external audits, with focus on external audits, related to GCP, GLP and GMP activities according to company procedures/policies and applicable regulations/guidelines. The person in this position will write audit reports and interact with the vendors/departments to complete action items and any long-term follow-up. This position will require domestic and international travel.

Responsibilities for this position:
Coordinate and conduct clinical site, IRB, and CRO audits. Coordinate and conduct vendor audits. Assist with internal department audits. Complete audit reports in a timely manner Manage resolution of any observations or corrective actions. Write Standard Operating Procedures and auditing templates. Maintain up-to-date working knowledge of national and international standards and guidelines related to GMP, GCP and GLP. Assist QA department with quality issues. Provide oversight, guidance and training as subject matter expert. Assist with other departmental duties.

Qualifications of the ideal candidate:
BS in life science or equivalent. Minimum of 5 years of QA experience with at least 2 years of direct GCP auditing experience within a pharmaceutical/biotech environment. Knowledge of regulations/guidelines pertaining to GXP with a focus on GCP. Excellent organization and communication skills (oral and written). Ability to work independently and within set deadlines. Excellent interpersonal skills. Good working knowledge of computer software such as Microsoft Office, Excel, Filemaker Pro or other database systems. Experience with document management systems is a plus.