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 Senior Quality Specialist to join our Boston locations. Responsibilities include:

Coordinate site training program to ensure compliance among clients, ACoD staff, and regular onsite vendors. Review deviations for closure, assist with root cause analyses when required, and maintain CAPA records Ensure quality records are closed in a timely manner such as deviations and CAPAs Oversee environmental monitoring program review and related investigations Oversee the review of site specific forms for adherence against approved procedures such as cleanroom cleaning forms, shipping forms, and raw material disposition forms. Lead regular meetings around quality records or root cause analyses investigations Work with other departments to obtain supporting documentation for quality records as needed Performance reviews and coaching for direct reports onsite Assist Quality management with coordination of audit preparation, participate in site audits, and execution of internal site audits Compiling quality related metrics to support quality management review Aid in the incorporation of new clients into the facility Execute and adhere to internal ACoD and client Material Management standards and specifications when additional support is needed Maintain, retain, and/or draft site quality documentation such as quality SOPs, log forms, and material files Potential travel to other sites in support of training and assisting of local ACoD facilities