Department: Azzur Cleanrooms On Demand Boston LLC
Job Functions and Responsibilities:
A) Responsible for maintaining the following Primary Tasks:
- Provide global Quality oversight of the global validation program
- Global Quality representative on all new construction or related global engineering projects
- Coordinate global and site Quality resources as needed for global engineering projects
- Collaborate with the global validation team in the maintenance of the global validation program
- Monitor requalification timelines to ensure global compliance
- Compile appropriate metrics related to the validation program, including tracking of requalification activities.
B) Responsible for maintaining the following Secondary Tasks:
- Train site Quality personnel on validation review and expectations
- Support internal/external audits and required responses CAPA/actions, as neededz.
C) Individual Requirements:
- Handling multiple responsibilities and job tasks (multi-tasking) as needed.
- Demonstrating attention to detail.
- Flexibility with work requirements, work environment, and fast-paced/changing job needs.
- Ability to know when to ask for help and when to pause for leadership decisions.
- Ability to train and mentor Quality Engineers.
D) Promoting teamwork by:
- Collaborating with co-workers.
- Attending staff meetings as required.
- Meeting individual company goals as established.
- Establishing rapport and maintaining positive communication with others, demonstrating respect and support, cooperating, and flexibility with change.
- Adhering to company and department policies.
Required Work Experience:
- 3+ years of experience within a QA validation or validation function
- GMP experience
- 5+ years of experience within a QA validation or validation function
- Previous experience in site development and launch is highly preferred
- Previous experience in computerized system validation is highly preferred
- Supervisory experience is preferred.
- Microsoft Office
- Basic GMP and GDP
- ISPE Baseline Guide: Commissioning and Validation and/or GAMP 5 (or similar equivalent validation guidance documents)
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.#LI-PK