Department: DNU - Azzur Cleanrooms On Demand Boston LLC
Responsible for maintaining the following Primary Tasks:
- Supporting client audits and regulatory inspections of COD facilities, including hosting where needed
- Maintain training materials and train personnel on external audit practices at Azzur
- Support response to and remediation of external audit findings
- Work with COD Site and Global teams cross-functionally to ensure the completion of remediation activities related to external audits.
- Track and report external audit outcomes, metrics, and remediations to Global Audit Systems Program Manager
- Assist in the creation and maintenance of support tools for external audits, such as work instructions and audit playbooks
- Support improvement initiatives related to the external audit program
- Travel to COD facilities throughout the US to support audit readiness and ensure audit performance when necessary
- Work with client teams to schedule and support client audits.
- Work with client and external teams to provide documentation of audit remediation activities and updates.
Responsible for maintaining the following Secondary Tasks:
1. Support and/or perform internal audits of COD sites when required
2. Train personnel on internal auditing practices at COD
3. Work with Site and Global teams cross-functionally to ensure the completion of remediation activities related to internal audits
4. Assist in the creation and maintenance of support tools for internal audits, such as templates and work instructions
5. Track and report internal audit outcomes, metrics, and remediations to Global Audit Systems Program Manager
● 6-8 years of experience supporting, hosting, and/or performing GMP audits of quality management
systems and GMP facilities.
● Audit hosting experience is highly preferred
● Regulatory inspection experience
● External certification in Auditing or the desire to obtain such credentials.
● GMP and GDocP
● Industry expectations/standards/guidance for GMP
● Bachelor’s degree or higher in a scientific discipline (Equivalent work experience relevant to the
position may be considered.)
Fulltime Employment with Azzur can offer you:
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
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.
We expect all Azzur Employees to:
- Put Others First,
- Have the Courage to Take Action,
- Take Personal Responsibility, and
- Have Fun!