Sr Quality Assurance 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 who will, under minimal supervision, execute tasks by the Azzur Cleanrooms on Demand (ACoD) quality management system; including but not limited to coordinating site training for compliance, environmental monitoring program review, investigations, maintain and review Quality records and ensure timely closure, documentation control, implementing site improvements, compiling quality-related metrics, and support client need per established agreements.


Essential Functions:

    1. Coordinate site training program to ensure compliance among clients, ACOD staff, and regular onsite vendors.
    2. Review deviations for closure, assist with root cause analyses when required, and maintain CAPA records.
    3. Ensure quality records are closed promptly such as deviations and CAPAs
    4. Oversee environmental monitoring program review and related investigations
    5. Oversee the review of site-specific forms for adherence to approved procedures such as cleanroom cleaning, shipping, and raw material disposition forms.
    6. Lead regular meetings around quality records or root cause analyses investigations
    7. Work with other departments to obtain supporting documentation for quality records as needed
    8. Assist with and ensure client quality requests are completed promptly
    9. Responsible for performance reviews and coaching for direct reports onsite
    10. Assist Quality management with the coordination of audit preparation, participation in site audits, and execution of internal site audits
Requirement:
  • Bachelor's degree in engineering, science, or equivalent
  • 5-7 years of experience in Quality roles in a GMP environment or one with related job skills
  • Supervisor or management experience
  • Cleanroom experience is highly preferred
  • Previous experience making quality decisions
  • Environmental monitoring or cleanroom microbiological experience
  • Documentation control and drafting 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 COD 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 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 needing 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.

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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