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QA Associate

Job Description:

The QA Associate will contribute to maintaining Corcept’s Quality System. This role’s primary responsibility is to create and maintain an Electronic Document Management System including developing a file structure system.


  • Create, implement, and maintain an electronic validated document archive system (EDMS) for Corcept. Develop a file structure system and naming convention for hard copy and electronic documents.
  • Process and analyze Document Change Requests (DCRs) and manage Biennial Review process
  • Comply with quality systems policies and procedures, and perform document revisions and periodic reviews
  • Provide logistical support to ensure proper closure of deviations, investigations, complaints and CAPAs
  • Track and follow up on external and internal audits and observations to ensure timely execution and closure
  • Assist in managing Corcept GxP Training program via ComplianceWire
  • Support internal and external inspections
  • Assist in creating periodic reports and metrics on various QA Systems to be sent to executive management


  • Bachelor’s degree required.
  • 2+ years’ experience in Quality Assurance in a GMP industry.

Preferred Skills, Qualifications, or Technical Proficiencies:

  • Strong proficiency with Sharepoint and other computer and electronic systems
  • Knowledge of 21 CFR 11, 210 and 211.
  • Exercises judgment within well-defined and established procedures and practices to determine appropriate action.
  • Detail-oriented with good organization and time management skills.
  • Excellent verbal and written communication skills
  • Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint).

If you are interested, please submit your resume by email to

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