Quality Systems GxP Training Specialist II

Corcept Therapeutics•Redwood City, CA
•$106,200 - $124,900•Hybrid

About The Position

The Quality Systems GxP Training Specialist II is a core member of Corcept’s Quality Systems team and supports activities and tasks for the GxP training program. The role requires an adaptable self-starter who can independently assess issues and propose solutions for systems such as ComplianceWire, which is used to manage training compliance. The 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. The position is based at Corcept’s headquarters in Redwood City, California.

Requirements

  • Excellent organizational skills and the ability to manage multiple competing tasks.
  • Excellent communication skills and the ability to collaborate with stakeholders across departments.
  • Applicants must be currently authorized to work in the United States on a full-time basis.

Nice To Haves

  • Experience with electronic Learning Management Systems; ComplianceWire LMS and Veeva Training are preferred.
  • Experience supporting GxP training programs for life sciences.
  • Proficiency with MS Office applications, including Excel, Word, Visio, and Teams.
  • BA/BS degree in a scientific, technical, or engineering field.
  • Five or more years of experience in pharmaceutical or life sciences organizations.

Responsibilities

  • Perform administrative tasks in the LMS, including creating training items or curricula, supporting system enhancements, troubleshooting user-account or training-access issues, and monitoring and sharing reports to drive training compliance.
  • Support cross-functional GxP Training Leads in strengthening training compliance through instructor-led training, reports and metrics, and education on the GxP training matrix.
  • Assess training qualification materials, including SOPs and work instructions, to ensure they are appropriately added to training curricula across GxP departments.
  • Assess existing curricula to determine whether additional training items, such as work instructions, should be added to support learning.
  • Support onboarding by working with HR, IT, and managers to identify training roles and requirements before making LMS assignments.
  • Support hiring managers in understanding the GxP training matrix and work with GxP Training Leads to determine whether revisions are required.
  • Support supplemental training activities, including on-the-job and instructor-led training.
  • Collect and report training metrics using LMS reporting functionality.
  • Design dashboards to increase visibility into department-level training compliance.
  • Identify and escalate gaps and discrepancies in the GxP training program and propose remediation solutions.
  • Assist with training attendance records, cataloging and filing, and uploading completed forms into the LMS.
  • Assist with implementing new LMS enhancements or systems.
  • Capture detailed meeting minutes, action items, and key decisions.
  • Assist in drafting internal communications for events and training status reports.
  • Coordinate and schedule lunch-and-learn sessions, office hours, and other supplemental training events.
  • Respond promptly to email inquiries and user-support questions using ticketing systems such as Zendesk.
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