Quality Assurance Associate (GCP Exp Required)

Job Summary

Description Quality Assurance Associate (GCP Exp Required)

Job Responsibilities

General Profile

• Assists in the tracking of planned and scheduled audits in the enterprise quality management system.
• Updates audit schedules and calendars as requested by management.
• Assists in gathering documentation required by auditors for audits and inspections (e.g. training records, organizational charts).
• Assists auditors in obtaining follow-up information during customer audits and regulatory inspections.
• Enters audit-related data into the enterprise quality management system.
• Maintains, files, and archives relevant Quality Assurance (QA) documentation.

Supervision

• Normally receives detailed instructions on day-to-day work and detailed instructions on new assignments.

Other tasks

• Performs other work-related duties as assigned.
• Minimal travel may be required (up to 25%).

Qualifications

• Requires a Bachelor's degree or equivalent with minimal experience in a health care or clinical research environment.
• Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency).
• Able to handle multiple tasks to meet timelines in a dynamic environment.
• Strong organizational, presentation and interpersonal skills.
• Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.
• Well-developed communication skills and the ability to write necessary documentation (e.g. tools).

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