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 and proven communication skills; or an equivalent combination of education and/or experience in a related field.
• Strong team player with the ability to work across multiple disciplines.
• Effective communicator (verbally and in writing) and self-starter.
• Ability to handle multiple projects simultaneously.
• Must be able to do work independently, recognizing what needs to be done and accomplishing it with minimal supervision.

Desired But Not Required:

• Experience establishing a document control process.
• Experience supporting operational excellence and continuous improvement through investigational skills, CAPA, effectiveness checks, and quality event trending/reporting.
• Experience working as a quality professional under 21 CFR 58 and 21 CFR 11.
• Experience with Veeva Quality Suite Platform.

At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.

Why You Will Love Working Here:
We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program (did we mention we have an onsite gym with state-of-the-art equipment and ping pong table?), to financial planning and legal assistance, we make sure to take care of our own.

• Health, Dental, and Vision insurance that starts on your first day at AmplifyBio!
• Competitive Compensation Package
• We take work-life balance seriously and we back it up with a FLEXIBLE PTO policy!
• Generous paid parental leave
• Wellness and Self-Care Programs
• 401(k) match
• Tuition Reimbursement
• EAP/work-life support system
• A fun work environment where everyone’s voice matters!
• An Opportunity to Change the World!!!

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. 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.