Quality Assurance Specialist II

Quality Assurance Specialist II

Location: Waltham, MA

Department: Azzur Cleanrooms-On-Demand-Services LLC

Job Description

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:

• Bachelor's 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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