Quality Systems GxP Training Specialist II

Corcept Therapeutics•Redwood City, CA

6d•Hybrid

About The Position

The Quality Systems GxP Training Specialist II is a core member of Corcept’s Quality Systems team and supports activities for the GxP training program. The role requires an adaptable self-starter who can independently assess issues and propose solutions for systems used to manage training compliance, such as ComplianceWire. The position reports to the Sr. Manager of Document Control and GxP Training and is hybrid, typically requiring on-site presence three days per week. The role supports administration and improvement of the Learning Management System (LMS), training curricula, compliance reporting, onboarding, supplemental training, and user support. It collaborates with GxP Training Leads and cross-functional teams to identify training requirements, assess program gaps, and propose remediation. The position also supports training events, communications, records, and LMS enhancements.

Requirements

Excellent organizational skills and the ability to manage multiple competing tasks.
Excellent communication skills and the ability to collaborate with stakeholders across various departments.

Nice To Haves

Experience with electronic Learning Management Systems; ComplianceWire LMS and Veeva Training are preferred.
Experience supporting GxP training programs in 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 LMS administrative tasks, 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, and 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 assigning training in the LMS.
Support hiring managers in understanding the GxP training matrix and work with GxP Training Leads to determine whether revisions are needed.
Support supplemental training activities, including on-the-job training and instructor-led training.
Collect and report training metrics using LMS reporting functionality.
Design dashboards to improve department-level visibility into 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 implementation of LMS enhancements or new 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 through ticketing systems such as Zendesk.