Department: Azzur Cleanrooms On Demand Boston LLC
Azzur Group is looking for Quality Assurance Manager who will be responsible for supporting and maintaining the QMS and GMP compliance for the Boston region's Cleanrooms On-Demand facilities. This position requires physical presence within Waltham, MA, and Burlington, MA facilities as needed to meet timelines and company goals and remote work. This position will work closely with site Quality Managers to meet company and site objectives.
- Bachelor's degree in a scientific discipline
Required Work Experience:
- 8 years of experience in a GMP environment, previous experience in Quality Control or Quality Assurance in the biopharma/medical device industries.
- Experience with supplier quality and quality agreements
- Experience handling and lead internal and external audits
- Experience with handling deviations, CAPA records, and Change Controls in a GMP environment.
- Environmental Monitoring experience related to addressing excursions and out-of-specification results
- Cleanroom operations experience such as gowning and cleaning practices.
- Working knowledge of FDA and cGMP regulations and documentation practices.
- An understanding of installation and operational qualification practices related to cleanroom construction, controlled temperature unit qualification, and warehouse qualification.
- GMP decision making with documented justifications
- Microsoft Office
- Leadership and team development, working within teams
- Technical writing and deviation / CAPA / Change Control writing
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™.
The Cleanrooms On-Demand model is an alternative to building out new cleanrooms or utilizing a CMO. Our clients use the cleanroom space and facility infrastructure (such as EM, waste management, security, etc.) with the option to add on additional services as needed while maintaining ownership of their IP and their process. In essence, we provide the GMP envelope around the clinical manufacturing activities that our clients perform in our cleanrooms. The goal for our clients is an accelerated timeline to clinic, flexibility, and cost savings.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays a vital role in developing top-quality talent, fostering more incredible innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.