Quality Specialist II

Location: Devens, MA
Department: Azzur Cleanrooms-On-Demand-Services LLC

Job Description

Azzur COD is seeking a Quality Specialist II  Azzur COD. The Quality Specialist II executes tasks in accordance with Azzur COD QMS, including but not limited to Environmental Monitoring Program review and related investigations, Processing Deviations and CAPA records, Reviewing and approve sit specific forms, recommending and implementing Site improvements, compiling Quality related Metrics, approving disposition of client raw materials, scan required client documents to meet quality agreements and support internal/external Audits as needed. 

WORKING DAYS: MONDAY- FRIDAY           

Job responsibility:          

  • Processing deviations and CAPA records.
  • Environmental monitoring program review and related investigations.
  • Review and approve site-specific forms to adhere to approved procedures, such as cleanroom cleaning, shipping, and raw material disposition forms.
  • Scan required client documents in a timely manner per approved client quality agreements
  • Execute and adhere to internal ACoD and client Material Management standards and specifications.
    • Compiling quality-related metrics to support quality management review.
    • Support internal/external audits and required responses/CAPA actions.
    • Aid in the incorporation of new clients into the facility.
    • Potential to travel to other sites in support of training and assisting of local ACoD facilities

       

Requirements          

  • 2-3 yrs experience 
  • GMP experience is highly preferred
  • Cleanroom experience is highly preferred
  • Material Management Experience
  • Previous experience making quality decisions

Required Education          

        
        Bachelor of Science or Bachelor of Arts in a scienctic 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:          

Who we are:          

Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 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.          

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