Quality Engineer/Specialist- 1st Shift

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

Job Description

Azzur Group is looking for a Quality Specialist, who under general supervision, performs and verifies GMP activities per approved procedures to support Clean room and raw material PROGRAM OPERATIONS for internal and client manufacturing operations at Azzur Cleanrooms On Demand (COD). This position will be for the first shift of the workday.


Responsibilities :


Perform and verify GMP raw material management per approved procedures. Support Internal and Client Quality Management Systems. 

Support quality systems that document the cause and effect of events that deviate from normal operations. Implement corrective and preventive actions (CAPA).

Provide onsite client support during cleanroom operations to ensure client business needs are executed as planned. This support can include off-hour support (weekday evenings and weekends).

Maintain the facility in a state of audit readiness. Ensure operations are being performed correctly per approved procedures





Required Education:

  • Bachelor’s degree or higher in a scientific discipline (Equivalent work experience relevant to the position may be considered.)
  • 1-2 yr. Experience in a Quality position.
  • GMP experience is preferred. 

 

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:

The Cleanrooms On Demand model is an alternative to building out new cleanrooms or utilizing a CMO.  Our clients utilize the cleanroom space and facility infrastructure (such as EM, waste management, security, etc.) with the option to add on additional services as needed, while maintaining ownership of their IP and their process.  In essence, we provide the GMP envelope around the clinical manufacturing activities that our clients perform in our cleanrooms.  The goal for our clients is an accelerated timeline to clinic, flexibility, and cost savings.

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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