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QA Associate / Sr. Associate

Job Description:

The QA Associate / Sr. 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.


Responsibilities:

  • 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, perform SOP revisions and periodic reviews
  • Provide 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
  • Manage the Corcept GxP Training program via ComplianceWire
  • Support internal audits and external regulatory inspections
  • Create periodic reports and metrics on various QA Systems to be sent to executive management


Requirements:

  • Bachelor’s degree required
  • 2-5 years’ experience in Quality Assurance in the bio/pharmaceutical industry
  • Strong proficiency with Sharepoint and other computer and electronic systems


Preferred Skills, Qualifications, or Technical Proficiencies:

  • Knowledge of 21 CFR 11, 210 and 211.
  • Exercises judgment within well-defined and established processes and practices to determine appropriate action.
  • 4
  • Detail-oriented with good organization and time management skills.
  • Ability to work independently and demonstrate 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 hr@corcept.com

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