What are the responsibilities and job description for the Quality Specialist II position at Azzur Group?
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:
Required Education:
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:
- Processing deviations and CAPA records
- Environmental monitoring program review and related investigations
- Review and approve site specific forms for adherence against approved procedures such as cleanroom cleaning forms, shipping forms, and raw material disposition forms
- Execute and adhere to internal ACoD and client Material Management standards and specifications.
- Train new staff and clients on quality processes and procedures
- Lead occasional or weekly meetings around quality records or root cause analyses investigations
- Work with other departments to obtain supporting documentation for quality records as needed
- Ensure client quality requests are completed in a timely manner
- Compiling quality related metrics to support quality management review
- Support and participate in internal/external audits and required responses/CAPA actions
- Aid in the incorporation of new clients into the facility
- Potential to travel to other sites in support of training and assisting of local ACoD facilities
Required Education:
- Bachelor's degree or higher in a scientific discipline, or equivalent experience
- 1-2 years experience in Quality role or one with related job skills required; 3 years preferred
- GMP and Cleanroom experience is highly preferred
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
