Quality Assurance Consultant

Location: Greater Boston Area



Essential Duties and Responsibilities

  • Review and approve batch records in support of product release
  • Participate or lead in deviation investigation review and approval
  • Approve CAPA and change control documents and activities
  • Author, review and approves GMP procedures and validation deliverables
  • Supports internal and external audits
  • Maintains third-party vendor relationships
  • Advises in development of metrics and KPIs for approved QMS
  • Develops and maintains quality agreements


Qualifications

  • BS in Engineering, Science or equivalent.
  • 5 - 8 years of experience in Quality Assurance in the biotechnology or pharmaceutical industry.
  • Must be flexible and adaptable to a fast-paced, rapidly changing environment.
  • Strong interpersonal skills and ability to work in a team environment
  • Expert in GxP and regulatory requirements
  • Excellent customer service skills, you must be able to interface professionally and appropriately with the client.
  • Excellent written and verbal communication; excellent technical writing skills.
  • Highly motivated and organized with high attention to detail.
  • Proficient in Microsoft and Google Suites.
  • Must have reliable transportation and the ability to travel in the New England region.