PRAHS

Returning Candidate?

2017-42388

2017-42388

Title 
Quality Assurance Associate (TQA and Vendor Negotiation experience required)
Job Locations 
-
US-PA
US-NJ
Posted Date 
2/16/2018

More information about this job

Overview

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.

Responsibilities

  • 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
 

Qualifications

  • 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




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

Options

Share on your newsfeed

Connect With Us!

Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!