Quality Assurance Validation (QAV) Consultant

Location: Greater Boston Area

Job Description

Azzur is currently looking for QAV Consultants for multiple site-based roles in the Greater Boston Area. Below is a list of potential responsibilities that may vary project to project.

Ideal Qualities

  • Must be flexible and adaptable to a fast-paced, changing environment.
  • Strong interpersonal skills and ability to work in a team environment.
  • Excellent customer service skills, must be able to interface professionally and appropriately with client.
  • Excellent written and verbal communication; excellent technical writing skills.
  • Highly motivated and organized, high attention to detail.
  • Proficient in Microsoft and Google Suites.
  • Must have reliable transportation and ability to travel in the New England region.
  • BS in Engineering, Science or equivalent.
  • 2-6 years of industry experience in a Quality or Validation Department.

Essential Duties and Responsibilities

Project Responsibilities May Include:

  • Write, generate, execute, and/or review life cycle documentation (FAT, SAT, IQ, OQ, PQ).
  • Initiate and perform investigations to close out deviations or discrepancies. Ensure corrective actions are resolved in a timely manner.
  • Review and contribute to change control documents. Provide sound validation/verification assessments.
  • Write reports to summarize validation, verification, and/or commissioning activities.
  • Support the resolution of regulatory observations or manufacturing site issues.
  • Perform field validations on various equipment, processes, and/or utilities.
  • Develop Project Plans for small to medium size projects.
  • Carries out duties in compliance with all local, state, and federal regulations and guidelines including the FDA, EPA, and OSHA.
  • Complies with all client site policies and procedures.
  • Experience in more than one area desired. Any blend of equipment, utilities, process, cleaning, facilities, commission & qualification, documentation, and document review is preferred.

Azzur Responsibilities:

  • Execute and deliver on all assigned work ensuring customer satisfaction.
  • Represent Azzur at client sites; be punctual and reliable.
  • Provide recommendations for improvement to client as needed or observed.
  • Report weekly project status to Director of Engineering.
  • Attend and engage in Azzur events and happenings.
  • Complies with all Azzur agreements, policies, and procedures.