Department: Azzur Cleanrooms On Demand Boston LLC
About Azzur Clean Rooms On Demand
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
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 major hurdle. To address the unique needs of start-ups in your position, Azzur Cleanrooms on DemandTM 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 DemandTM 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.
This role will support day-to-day operations to make sure the facility and technical operations run smoothly. The ideal candidate will independently execute routine operations and be allowed to lead operations improvement projects.
Essential Duties and Responsibilities:
The Operations Associate of the COD-Waltham site will support the internal operations team.
- Be available to work a flexible 8-hour shift during the main hours of operations, Monday-Friday 6:30 am – 8:30 pm. In addition to Monday - Friday, occasional weekend support may be required.
- Assist with shipping, receiving, and warehouse duties
- Assist with equipment set-up, maintenance, and calibration.
- Assist with Environmental Monitoring, Utility monitoring, and all cleanroom support activities.
- Ensure that cleanrooms are running according to documented procedures.
- Maintain, create, and revise electronic documents
- Assist early phase manufacturing companies, vendors, and visitors in a friendly and professional manner
- Restock and maintain a professional atmosphere throughout the facility, including the office, the cleanrooms, and shared conference and breakroom spaces
- Assist with scheduling, operations management, and enforcement of facility regulations
- Work in collaboration with Azzur COD staff as needed on special projects to improve the organization
- On a limited basis, travel may be required for training purposes or to support the Waltham COD site
- Support Operations Manager in providing appropriate training to new Employees and Clients of COD
Basic Qualifications & Position Requirements
- High School Diploma with job experience, Technical Certificate or Associate's degree
- Associates or Bachelor’s Degree in Science, tech studies or related field preferred
Required Work Experience:
- Competent using computers and software programs
- Strong organizational skills and ability to prioritize multiple tasks and/or projects
- Must be able to exert up to 40 pounds of force frequently.
- Experience in a regulated industry such as biopharma or medical device is preferred.
- Customer service experience is a plus but not required.
Computer literacy including Microsoft Office
Fulltime Employment with Azzur can offer you:
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
Who we are:
Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.