Quality Assurance Specialist

Location: Waltham, MA
Department: Azzur of NE, LLC

Job Description

Azzur Group is looking for a Quality Assurance Specialist in the Greater Boston area to join our team! This is great opportunity expedite your career growth through exposure to projects across multiple client sites and functions! If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!

This is a full-time position with a competitive salary and benefits package

Responsibilities:

The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.

  • 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
  • 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.

Requirements:

  • 5+ years of experience in an FDA regulated, manufacturing environment within the biotechnology or pharmaceutical industry.
  • Excellent written and verbal communication skills; excellent technical writing skills.
  • Strong interpersonal skills and the ability to work in a team environment.
  • Expert working knowledge of FDA and cGMP regulations and documentation practices.
  • Proficient in Microsoft Word, Excel, and PowerPoint.
  • Must be willing to travel around New England to various client sites

About Us

Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, and consulting services. At Azzur, we look to hire full-time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments. Using our 4 Core Values as guidance, we expect all Azzur Employees to:

  • Put Others First,
  • Have the Courage to Take Action,
  • Take Personal Responsibility, and
  • Have Fun!

Full time employment with Azzur can offer you:

  • Flexible PTO
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays
  • Company provided laptop


Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.

 



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