Senior Quality Specialist

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

Requirements

• Bachelor’s degree or higher in a scientific discipline, or equivalent experience required; Master's Degree preferred
• 5-7 years experience in Quality roles in a GMP environment or one with related job skills
• Supervisory or management experience preferred
• Cleanroom experience is highly preferred
• Environmental monitoring or cleanroom microbiological experience preferred
• Documentation control and drafting experience

• ASQ certification preferred
• Microsoft Office required
• GMP and GDP knowledge required

Benefits

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