Clinical QA Audits Specialist

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Primary Responsibilities: 

• Plan and conduct audits of CROs, vendors, clinical trial sites, and documentation associated with clinical trials. Assess compliance with applicable regulations and standards.
• Conduct internal audits of Clinical GCP processes for adherence to SOPs, company policy, and regulations/standards.
• Contribute to the review of the internal procedures related to the planning, conduct and oversight of clinical audits.
• Prepare audit reports and discuss findings with auditees and internal customers. Track and follow up on the resolution of audit findings.
• Provide guidance to Clinical staff in resolving audit findings in a compliant manner.
• Assist internal groups in preparing for inspections by regulatory agencies and participate in on site regulatory inspections as appropriate.

 

Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. 

• You have a Ph.D. Master, Bachelors in pharmaceuticals or life sciences related field.
• You have at least 3 years of practical experience in GCP and GCLP quality assurance or compliance.
• You are available to travel.

 

Location: NORTH AMERICA : EE.UU. : NC-RTP:USNC0001 - RTP NC-Headquarters 

 

Learn more about Grifols