About Azzur Cleanrooms on Demand™

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 Demand™ 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 Demand™ 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.

The Quality Specialist II will execute tasks in accordance with the Azzur Cleanrooms on Demand (ACoD) quality management system; 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
• Approving disposition of client raw materials
• Scanning required client documents to meet quality agreements
• Supporting internal/external audits as needed

Education:

• Bachelors degree or higher in a scientific discipline, or equivalent experience

Work Experience:

• 1-2 years experience in Quality roles or one with related job skills; 3+ years Quality experience preferred
• GMP and Cleanroom experience is highly preferred

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