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Quality Assurance Associate (TQA and Vendor Negotiation experience required)
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Performs review, coding, and entry of audit report findings, assists with facilitation of Corrective and Preventative Actions (CAPAs), and participates in GCP related projects.  Participates in facilitating or co-audits as experience increases and proficiency is demonstrated.


  • Applies knowledge of ICH GCP to interpret audit findings and conduct peer reviews (as appropriate)
  • Generates initial response to general ICH GCP questions
  • Facilitates and supports  CAPA tracking, generation, review, and closure
  • Facilitates tracking of escalated issues to resolution
  • Provides input and support to projects the QA department is working on
  • Excellent writing and communication skills
  • Communicates with multiple levels within the organization
  • Supports implementation of revised processes and procedures


  • Experience in clinical research organization is preferred, however, must possess a technical knowledge that is applicable to clinical drug development and possess the expected ability to master the needed understanding of clinical and technical areas not already known.
  • Basic understanding of ICH GCP, FDA CFR, and EU directive
  • Read, write and speak fluent English; fluent in host country language required.
  • An undergraduate degree or its international equivalent from an accredited institution required; Preferably in the health-sciences or computer sciences


To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


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