Senior/GLP QA Auditor

Do you want to be part of a growing world-class organization focused on bettering our world? Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!                                        

AmplifyBio is a newly established, commercially focused preclinical CRO that was created as a Battelle spin-off. Aligned with, and supported by leading life sciences-focused investors, we partner with our clients to provide preclinical CRO services from single study and through full IND enabling studies. We have a strong focus and commitment to helping accelerate the commercialization of advanced therapies such as cell and gene therapies and vaccines. 

Moving forward we will combine continuous improvement and innovation to become the preferred preclinical CRO in the industry, by working in partnership with our clients, and leveraging state of the art technologies and platforms we will enable our customers to accelerate and improve the product development cycle, from concept to commercial.

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians and specialists across a variety of disciplines. Our chemists, biologists, veterinarians, data scientists, engineers, pathologists, and other experts collaborate to deliver new and exciting breakthroughs. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.

AmplifyBio is seeking to hire a SR./GLP Quality Assurance Auditor to join our growing team!!! 

The Sr./GLP QA Auditor Conducts audits and performs inspections to assure compliance to federal regulations, AmplifyBio standards, client specifications, internal policies, and any other applicable guidelines.

What You’ll Do Here: 

• Audits protocols, raw data, documents, records, reports, and inspects work being performed to assure compliance to regulatory requirements, standards, specifications, internal policies, and any other applicable guidelines.
• Performs inspections of AmplifyBio facilities and corresponding documentation to assure compliance to requirements. Issues recommended actions and assesses corrective actions based on observation(s). 
• Reports audit findings to project leadership and management.
• Advises operations regarding issues observed during inspections to mitigate risk. 
• May review project planning documents (technical protocols, project plans, test plans, etc.) for compliance with stated requirements.
• Utilizes knowledge of specific instrumentation and equipment, laboratory techniques, and current FDA industry guidance to advise on compliant operations.
• Interprets and applies existing and new regulatory requirements and industry standards to operations methods and practices. 
• Develops and executes Quality Assurance Audit Plans per project.
• Proven leadership with mentoring responsibilities.
• Demonstrates initiative and accountability, with ownership of complex projects.
• Demonstrates ownership of assignments with accountability and instills trust in project team.
• Proven risk management skills including mitigation strategies.
• Established internally as a regulatory subject matter expert and amongst peers as a leader in the organization.
• Identifies compliance gaps and actively drives process/continuous improvement efforts to minimize risk to the organization.
• Drives change management through use of effective strategies and own skills in order to facilitate organizational change initiatives.

We Would Love to Hear from You If: 

• Bachelor’s Degree in a related field; 10 years of experience in a quality assurance program and proven communication skills; or an equivalent combination of education and/or experience in a related field.
• Experience in a GxP environment.

Desired But Not Required:

• Experience with System Validation and Method Qualification.
• Experience with electronic Quality Management Systems, Laboratory Information Management Systems and 21 CFR Part 11 compliance.
• Experience interacting with external audits and regulatory agencies.

At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivat