Quality Systems GxP Training Specialist

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. 

Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.

This role is a core member of the Quality Systems team and works on activities and tasks that support the GxP training program. This role requires an adaptable, self-starter that can independently assess issues and propose solutions for systems like ComplianceWire used to manage training compliance. This position reports to the Sr. Manager of Document Control and GxP Training.

This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities:

• Perform administrative tasks in the LMS including creation of training items or curricula, support for system enhancements, troubleshooting issues with user accounts or training access, and monitoring and sharing reports to drive training compliance
• Support cross-functional GxP Training Leads in strengthening training compliance using instructor led training, reports and metrics, and education on GxP training matrix
• Assess training qualification materials, including but not limited to SOPs and work instructions, ensuring they are appropriately added into training curricula across various GxP departments
• Assess existing curricula to determine if additional training items, like work instructions, should be added to support learning
• Support onboarding activities by working with HR, IT, and managers to identify training roles and requirements prior to making assignments in the LMS
• Support hiring managers in their understanding of the GxP training matrix and work with GxP Training Leads to determine if revisions are required
• Support supplemental training activities including on-the-job training and instructor-led training