Quality Specialist II

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.

We are looking for a Quality Specialist II to join our Boston locations. Responsibilities include:

1. Processing deviations and CAPA records
2. Environmental monitoring program review and related investigations.
3. Review and approve site specific forms for adherence against approved procedures such as cleanroom cleaning forms, shipping forms, and raw material disposition forms.
4. Execute and adhere to internal ACoD and client Material Management standards and specifications.
5. Train new staff and clients on quality processes and procedures
6. Lead occasional or weekly meetings around quality records or root cause analyses investigations
7. Work with other departments to obtain supporting documentation for quality records as needed
8. Ensure client quality requests are completed in a timely manner
9. Compiling quality related metrics to support quality management review.
10. Support and participate in internal/external audits and required responses/CAPA actions
11. Aid in the incorporation of new clients into the facility.
12. Potential to travel to other sites in support of training and assisting of local ACoD facilities

Requirements

Required Education:

•    Bachelor’s degree or higher in a scientific discipline, or equivalent experience

Required Work Experience: 

•   1-2 years experience in Quality role or one with related job skills required; 3+ years preferred

Preferred experience:

• GMP and Cleanroom experience is highly preferred

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)