Department: Azzur Princeton, LLC
We at Azzur Group are looking for an experienced QA Engineer Consultant to join our Azzur Consulting: Princeton team.
Quality Engineers must be able to demonstrate accountability, strong communication skills, and knowledge of project scopes within the biotechnology and pharmaceutical industries, for one or more projects within Azzur Group.
Essential Duties and Responsibilities:
- Possesses strong organizational, multitasking, and Technical Writing abilities, with a solid background in manufacturing processes and controls
- Critically reviews, writes or revises various types of documentation to ensure completeness, accuracy, and compliance including but not limited to manufacturing records for batch and material release, specifications, validation protocols and summary reports, regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, Request For Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls
- Assist and provide guidance on any nonconformance, deviation, or excursion that may occur, experience with deviations and CAPAs required
- Experience with Veeva and SAP preferred
- Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations, and standards
- Conduct risk assessments and provide a commissioning timeline of activities to identify and evaluate and prioritize risks associated with commissioning and qualifying
- Ability to work well independently and with minimum supervision and identify problematic deviations upfront
- Be able to help lead team in defining project strategies, developing goals, and ensures project scope is defined and controlled and requests outside the scope are identified within area of expertise
- Be able to clearly communicate on expertise to internal and external teams when needed
- Some travel may be required
- Minimum 5 years previous experience with quality projects within the biotechnology and pharmaceutical industries
- Experience with commissioning and qualification of utilities (compressed air), growth direct system, equipment and CSV qualification of cell and gene therapy equipment required
Education:Minimum of a Bachelor or equivalent discipline required
Full Time Employment with Azzur can offer you:
• Flexible PTO
• 401(k) match
• Bonus Eligibility
• Medical Benefits
• Paid Holidays
• Company provided laptop
Who we are:
Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, quality and consulting services. At Azzur, we look to hire full- time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments.
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 culture, ethnicity, gender and age 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.