Quality Assurance Associate

Ergomed • Raleigh, 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level