Sr Quality Specialist

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


Essential Functions:

    1. Processing deviations and CAPA records.
    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. Scan required client documents in a timely manner per approved client quality agreements
    5. Execute and adhere to internal COD and client Material Management standards and specifications.
    6. Train new staff and clients on quality processes and procedures.
    7. Compiling quality-related metrics to support quality management review.
    8. Support internal/external audits and required responses/CAPA actions.
    9. Aid in the incorporation of new clients into the facility.
    10. Potential to travel to other sites in support of training and assisting of local ACoD facilities.
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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