GMP 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, executes tasks in QMS, including but not limited to environmental monitoring program review and related investigations, processing deviations and CAPA records, reviewing and approving site specific forms, recommending and implementing site improvements, compiling quality-related metrics, approve disposition of client raw materials, scan required client documents to meet quality agreements, and support internal/external audits as needed.

Responsibilities :

  1. Processing deviations and CAPA records in a timely manner.
  2. Environmental monitoring program review and related investigations.
  3. Review and approve site specific forms for adherence against approved procedures such as cleanroom cleaning forms, shipping forms, and raw material disposition forms.
  4. Execute and adhere to internal ACoD and client Material Management standards and specifications.
  5. Train new staff and clients on quality processes and procedures
  6. Lead occasional or weekly meetings around quality records or root cause analyses investigations
  7. Work with other departments to obtain supporting documentation for quality records as needed
  8. Initiating, managing and closing change controls.
  9. Support materials management program including but not limited to review of shipping and receiving processes, raw material sampling, and release of raw materials intended for GMP use
  10. Ensure client quality requests are completed in a timely manner

Required Education:

  • Bachelor’s degree or higher in a scientific discipline (Equivalent work experience relevant to the position may be considered.)

  • 2+ years of experience in a Quality Assurance position.

  • 2+ years of experience in  CAPA , investigations and change control

  • Environmental monitoring experience is preferred. 
  • GMP experience is preferred. 


Preferred Education:

  • Bachelor’s Degree or higher in a scientific discipline



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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