1. Conducting and reviewing investigations and clients exceeded concerns levels.
2. Possesses the knowledge and ability to conduct and host client and regulatory audits professionally, ethically, and objectively.
3. Assumes the role of the CAPA coordinator. Responsible for overseeing the conduct of the CAPA and organizing meetings and updates as necessary.
4. Assists the change control coordinator and will assume a role where needed.
5. Maintains training records and documentation.
6. Conducts review of internal methods and protocols.
7. Reviews documentation such as raw data and reports, quality control records, quality assurance records, and reports for completeness, accuracy, and compliance with methods, protocols, guidelines, and regulations and Azzur Labs, LLC quality systems.
8. Assures proper control of laboratory documentation.
9. Responsible for the implementation, maintenance, and improvement of quality systems.
10. Collaborates with managerial reports and trends.
11. Provides guidance to peers regarding Quality and Regulatory issues.
12. Problem-solve quality issues to preserve the original timeline for various projects; tracking progress while accountable for quality system deliverables.
13. Accountable for overseeing the lab’s adherence to all relevant Quality requirements.
14. Analyze and identify opportunities to reduce process variation.

B) Reporting Opinions and Interpretations:

1. Understand the significance of deviations found concerning the normal use of materials tested
2. Communicate with clients on an ongoing basis to discuss the interpretation of test results, trend analysis, and matters regarding exceeded concerns levels, follow-ups, and reports.
3. Provides expert opinion, advice, and recommendations to the organization regarding quality processes.

Required Work Experience:

• 5-7 years of experience in quality-related activities.
• 2 years of experience managing staff.
• Knowledge of QA activities in a GMP-regulated field.

Benefits

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 over 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.