Quality Assurance Consultant

Location: Greater Boston Area

Job Description

Azzur New England is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever- changing healthcare field while simultaneously and organically exuding Azzur’s core values:

PUTS OTHERS FIRST, HAS THE COURAGE TO TAKE ACTION, TAKES PERSONAL RESPONSIBILITY & HAS FUN!


Essential Duties and Responsibilities

  • Review relevant documents for compliance to SOPs, quality systems, and regulatory requirements
  • Lead timely and effective resolution to deviations, investigations, audit observations and CAPAs
  • Participate in audits, manage auditing program, review reports and manage follow up activities
  • Suggest, review and prepare quality metrics and makes recommendations
  • Provide oversight of the audit programs
  • Provide ongoing guidance and ensure compliance with established systems, process, and procedures
  • Provide recommendations for continuous improvement of quality systems and procedures
  • Assist during regulatory inspections


Qualifications

  • BS degree in related science discipline or equivalent
  • 6-9 years of relevant experience