Senior Quality Specialist

Location: Boston Cleanrooms On Demand
Department: Azzur Cleanrooms-On-Demand-Services LLC

Job Description

Azzur Group is looking for a Senior 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). 


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.)

  • 5-7 yr. Experience in a Quality Assurance position.

  • Change Control and CAPA experience are required. 
  • GMP experience is preferred. 

 

Preferred Education:

  • Bachelor’s Degree or higher in a scientific discipline

 

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:
As you look to start your journey on the next cure that can heal patients and save lives, lack of space to manufacture and properly follow cGMP processes can be major hurdle. To address the unique needs of start-ups in your position, Azzur Cleanrooms on DemandTM is here to support production for early-phase partners, helping you accelerate your time to market. Truly unique to the industry, our on-demand cleanrooms as a service include cGMP-compliant cleanroom space, warehousing, and materials management. This allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs). Unlike working with a CMO, Azzur Cleanrooms on DemandTM mitigates risk, affording you full access and control to your IP, space, and activities. This is all backed by quality management consultants with decades of experience implementing phase-appropriate GMP for industry leaders.

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