Department: Azzur Labs, LLC
The quality manager's primary responsibility is to manage local COD Quality policies, procedures, and processes in compliance with cGMP standards and Azzur business processes.
- Aids in conducting and reviewing investigations of lab deviations and client exceeded concerns levels
- Possesses the knowledge and ability to conduct client audits in a professional, ethical, and objective manner.
- Assumes the role of the CAPA coordinator.
- Assumes the role of the change control coordinator.
- Maintains training records and documentation.
- Conducts review of internal methods and protocols.
- 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.
- Assures proper control of laboratory documentation.
- Collaborates with the implementation, maintenance, and improvement of quality systems.
- Understand the significance of deviations found with regard to the normal use of materials tested
- 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.
- Reviews opinions and interpretations expressed by testing personnel.
- 5-7 years of experience in quality-related activities or three years of experience and a minimum of two quality certifications
- 2-3 years of experience managing staff
- Experience in Microbiology is preferred.
- Bachelor of Science or Bachelor of Arts in a science field
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 a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, Cleanroom on-demand, Lab, and consulting services. Using our 4 Core Values as guidance, we expect all Azzur Employees to:
- Put Others First,
- Have the Courage to Take Action,
- Take Personal Responsibility, and
- Have Fun!
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 we operate.