Quality Assurance Associate

ErgomedRaleigh, NC
22h

About The Position

The QA Associate will support the QA team to ensure internal/external audits are developed, managed, maintained, and delivered in line with PrimeVigilance procedures. The QA Associate will conduct all activities described, including but not limited to:

Requirements

  • University degree in a scientific discipline, or equivalent industry experience

Responsibilities

  • supports audits (routine, due diligence, qualification) and inspections of Primevigilance performed by clients/third parties and regulatory authorities as agreed with Quality Audits Manager and/or Director, Quality.
  • Supports PrimeVigilance functional teams pre-, during and post-audit by clients or by internal QA function
  • Assists in client specific requests for audit scheduling
  • Assists in maintenance of trackers involved for audit related tasks and the maintenance of the SharePoint
  • Supports the oversight, maintenance, scheduling of audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities.
  • CAPA Support Activities
  • Supports in tracking of the vendor audit CAPAs.
  • Support in the facilitation and review of vendor CAPA responses
  • Input into the global audit CAPA tracker
  • Ensures documents and trackers from internal system and/or vendor audits initiated by Primevigilance, are kept up to date.
  • Assists in the development and maintenance of the internal risk assessments.
  • Conducts other ad-hoc activities as requested by Quality Audits Manager and/or Director, Quality.

Benefits

  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language
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