Sr. Quality Systems Specialist

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 leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics. 

The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)– Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) – Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) – Amplify's Manufacturing Enablement Center.   

About ASET West Jefferson, OH: AmplifyBio’s safety, efficacy, and toxicology unit (ASET) was launched as a preclinical CRO that spun out of Battelle in 2021 to address the changing needs of commercial organizations developing modern therapeutics. AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. Among the investments that AmplifyBio has made to empower preclinical assessments of advanced therapies is building a new state-of-the-art analytical laboratory to include molecular and immunological assays that assess critical safety and efficacy indicators for cell and gene therapies during preclinical studies

AmplifyBio is seeking to hire a Sr. Quality Systems Specialist to join our growing team!!!

The Sr. Quality Systems Specialist is responsible for providing oversight and guidance for the execution of quality processes within the Quality Management System (QMS) as part of the QS group. The Sr. Quality Systems Specialist will ensure that all quality processes (Deviation/CAPA, Training Administration, Document Control, etc.) are conducted in compliance with applicable regulations, client requirements, and AmplifyBio procedures and policies. They support working relationships with other department staff and personnel to drive operational efficiencies a continuous improvement mindset.

What You’ll Do Here:

• Guides the execution of Quality Event Reporting, Investigations, Corrective and Preventive Action (CAPA) program and Change Control processes.
• Supports the Quality Review Board (QRB) for quality event awareness, discussion, and action plan development, including trend analysis and reporting.
• Participating in the planning, development, creation, and implementation of training programs
• Maintaining up-to-date, correct, and accurate training records, such as trainee lists, schedules, attendance sheets, and so on
• Oversees the controlled document process using the electronic Quality Management System (Veeva QualityDocs) 
• Prepares Document Change Controls and monitors through completion.
• Acts as a Leader of Influence and a trusted Point of Contact for Operations staff.
• Maintains a thorough knowledge of all applicable regulations and AmplifyBio policies.
• Supports project deliverables, discusses project quality with management.
• Ensures QS procedures, manuals, and policies are followed.
• Supports the quality processes training program for CRO Operations, promoting organization awareness to foster a quality culture.
• Assists with implementation and maintenance of the electronic QMS, providing business administration oversight and engagement where needed.
• May assist QAU staff with assigned audits, critical phase, and facility inspections where necessary.
• Demonstrates ownership of assignments with accountability and instills trust in the project team. 
• Proven risk management skills including mitigation strategies. 
• Established internally as a Quality Management Systems 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 using effective strategies and own skills to facilitate organizational change initiatives. 

We Would Love to Hear from You If: 

• Bachelor’s Degree in a related field; 8 years of experience in a quality assurance program