Sr Quality Specialist

Location: Burlington Cleanrooms On Demand
Department: Azzur Cleanrooms On Demand Burlington LLC

Job Description

Azzur Cleanrooms on Demand (COD) is looking for a Sr Quality specialist to perform and verify GMP activities to support cleanroom and raw material program operations at all COD facilities in Burlington, MA.


Essential Functions:

  1. Ensures all incoming materials are tested and found to be of acceptable quality before use.
  2. Responsible for conducting both internal and external audits, as well as vendor approval.
  3. Assists in conducting investigations of laboratory deviations and client exceeded concern levels.
  4. Maintains training records and documentation.
  5. Reviews documentation, raw data and reports (ICP Analysis, Chemical Identification, Hazardous Drug Analysis, Titration, UV-Vis, Steam Quality, Method Validation), logbooks (all), calibration/qualification reports and data, quality control records, and other quality assurance records for completeness, accuracy, and compliance with methods, protocols, guidelines, regulations and Azzur Labs, LLC quality systems.
  6. Assures proper control of laboratory documentation.
  7. Maintains familiarity with laboratory testing as needed for review.
  8. May draft or review client notifications of exceeded levels.
  9. Collaborates with the implementation, maintenance, and improvement of quality systems.
Requirement:
  • Bachelors degree in engineering, science, or equivalent
  • 5-7 years experience in a quality role
  • GMP Experience
  • Raw Material Experience.

Benefits

Fulltime Employment with Azzur can offer you:

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

Who we are:

Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With over 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.

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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