Sr Quality Engineer

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 Engineer to perform and verify GMP activities to support cleanroom and raw material program operations at all COD facilities in Burlington, MA.


Essential Functions:

  1. Provide quality oversight of materials management, shipping, and receiving, aseptic raw material sampling per an approved specification, inventory control assignments, and various client required assignments. These duties ensure client and internal COD operations are performed in compliance with relevant site and client procedures and pertinent regulatory requirements. Typical duties include oversight and review of:
    1. Shipments and documented according to site and client procedures.
    2. Client material shipments in compliance with temperature control and chain of custody requirements.
    3. Raw material sampling forms and associated inventory control.
    4. Sign as Quality for the release of controlled raw materials intended for GMP use.
    5. Review of internal GMP operations to ensure compliance with relevant procedures and regulations.
    6. Support quality systems that document the cause and effect of events that deviate from normal operations. Implement corrective and preventive actions (CAPA). Examples are material handling excursions, controlled area environmental excursions, and facility operation service interruptions.
    7. Lead and/or support discrepancy investigation with cross-functional teams.
    8. Support Client specific needs beyond standard offerings as specified in the Statement of Work.
    9. Provide Quality representation in Client meetings as needed. Report and investigate discrepancies as required per internal and client procedures.
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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