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Quality Assurance Manager
3 months ago
- Conduct and review investigations of lab deviations and client exceeded concern levels.
- Possess the knowledge and ability to conduct and host client and regulatory audits professionally, ethically, and objectively.
- Assume the role of the CAPA coordinator. Responsible for overseeing the conduct of the CAPA and organizing meetings and updates as necessary.
- Assist the change control coordinator and will assume a role where needed.
- Maintain training records and documentation.
- Conduct review of internal methods and protocols.
- Review 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.
- Assure proper control of laboratory documentation.
- Responsible for the implementation, maintenance, and improvement of quality systems.
- Collaborate with managerial reports and trends.
- Provide guidance to peers regarding quality and regulatory issues.
- Problem-solve quality issues to preserve the original timeline for various projects; tracking progress while accountable for quality system deliverables.
- Accountable for overseeing the labs adherence to all relevant quality requirements.
- Analyze and identify opportunities to reduce process variation.
- B.S. in a scientific field required, Master's preferred.
- 5-7 years of experience in quality-related activities.
- 2 years experience managing staff.
- Knowledge of QA activities in a GMP-regulated field.
- Experience with Microbiology preferred
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.
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