Senior Quality Assurance Specialist

Location: Boston 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 Waltham 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 to 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 to support training and assist local ACoD facilities.
Requirement:
  • Bachelors degree in engineering, science, or equivalent
  • 5-7 years experience in a quality role.
  • CAPA/change controls experience
  • GMP Experience
  • Raw Material releasing Experience.
  • Environmental monitoring 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 CODAs 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 a 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.



Apply Now

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