This QA position is a member of the Quality team and provides QA support and oversight to ensure compliance with Good Clinical Practice (GCP), Pharmacovigilance Practices (GVP). In addition, support to the GLP and GMP areas will be provided as needed.
Areas of responsibility include:
- Coordinate, contribute to and support development and roll out of Clinical, Drug Safety, and Clinical QA standard operating procedures (SOPs); and GLP and GMP SOPs as needed.
- Coordinate and support audits of domestic and international clinical investigator sites, clinical service providers/CROs, trial master files, data/CRFs, and study documents (e.g., protocol, clinical study reports) for clinical trials.
- Serve as QA GCP representative at designated project meetings.