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:
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Environmental monitoring program review and related investigations
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Processing deviations and CAPA records
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Reviewing and approving site specific forms
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Recommending and implementing site improvements
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Compiling quality related metrics
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Approving disposition of client raw materials
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Scanning required client documents to meet quality agreements
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Supporting internal/external audits as needed
Education:
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Bachelor’s degree or higher in a scientific discipline, or equivalent experience
Work Experience:
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1-2 years experience in Quality roles or one with related job skills; 3+ years Quality experience preferred
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GMP and Cleanroom experience is highly preferred
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