We are looking for two contract resources to assist us with our current GCP and GLP QA workload (in-house QA activities and external auditing). Responsiblities include collaborating with Clinical Research / Clinical Operations personnel to ensure that clinical trials comply with SOPs, FDA regulations, and ICH/GCP guidelines. Provides expert GCP compliance and general QA support; acts as liaison between product development teams and QA. Plans, coordinates and conducts internal and external (both domestic and international) GCP-related audits.
- BS in a scientific discipline or equivalent.
- A minimum of 3-5 years experience in a Clinical Quality Assurance / Compliance role
- Working knowledge of Code of Federal Regulations and ICH Guidelines governing clinical research and familiarity with current initiatives.
- Knowledge of GLP regulations / auditing techniques preferred.
- Experience in developing and writing SOPs.
- Must be able to partner with a diverse group of staff/consultants with different strengths and skills and have the ability to prioritize work, manage multiple projects, while maintaining quality.
- Ability to work independently and as part of a team, detail oriented.
- Experience in international compliance / auditing a preferred.
On Assignment - 23 months ago