AmplifyBio Hiring for Sr QA Systems Manager (GMP) job in Columbus Full Time

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 company dedicated to building an integrated environment where clients can access technologies, platforms, capabilities, and safety testing for the scale up and commercialization of advanced therapies. We began as a CRO, spun out from the Battelle organization in West Jefferson, Ohio and are now proud to have added a site in South San Francisco dedicated to discovery, optimization, and characterization of client drug candidates and soon to launch facility in New Albany, OH.

The platforms and domain expertise at our New Albany site will fill the critical gap that exists between discovery and the clinical scale up of drug development. The team here is dedicated to helping clients understand the biological and immunological mechanisms and characteristics of their advanced therapies to ensure product consistency and prevent unexpected failures downstream.

We partner with our clients, 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’s next step forward in advancing medical breakthroughs, treatments, and cures for disease is to establish a Cell & Gene Therapy (CGT) manufacturing and development facility. We are seeking highly motivated individuals to help create and define a first-of-its-kind CGT facility at our new site in New Albany, OH.

AmplifyBio is currently seeking to hire a Senior/Quality Assurance Technology Manager – Electronic Compliance Systems to join our growing team!!!

The ideal candidate is an experienced Senior/Quality Assurance Technology Manager – Electronic Compliance Systems with a track record of success in implementing processes and systems to provide compliance oversight in support of software and infrastructure designed to support Cell & Gene Therapy GMP processing and understands biologics and/or cell therapy processes.

What You’ll Do Here:

• Act as QA subject matter expert and operational support for electronic systems including Veeva, ValGenesis, NetSuite and Benchling.
• Provide support and assistance to system administrators for issue resolution and change requests.
• Work with cross-functional team on regulatory, quality compliance strategies and execution in support of Upstream/ Downstream operations, software, automation, and infrastructure
• Identify process challenges and implement process improvements.
• Support requirements definition, solutioning and implementation.
• Review and provide feedback on product and architectural decisions to ensure product compliance with regulatory requirements.
• Hands-on technical configuration experience with workflow and vault objects.
• Work with the developers and other QA engineers to investigate issues and verify fixes.
• Establish and enforce quality processes within the software testing team, including risk assessment, test strategy and plan, execution of test cases, tracing requirements, and other standard operating procedures and work instructions.
• Quality Assurance approval authority of change controls and computer systems validation documents including Impact Assessments, Action Plans, and Risk Assessments, Protocols, and Reports.
• Review the reports in support of executed validation test script protocols.
• Support software vendor qualification activities including risk assessments and due diligence audits.
• Provide periodic operations reports and metrics to manager.
• Provide support during inspections and audits.

We Would Love to Hear from You If:

• B.S. degree in computer sciences or related field with 8+ years of quality assurance in biotech or pharma industry.
• Veeva System Administration Certification or Equivalent 4+ Years Experience.
• Database and Computer Networking Knowledge
• Experience Working on SaaS Enterprise Solutions
• Experience in GXP Environment.
• Experience with implementation and continuous improvement of electronic Quality Systems.
• Ability to communicate well across different disciplines and experience levels.
• Experience supporting regulatory inspections.
• Experience using risk management tools (FMEA, etc.).
• Knowledgeable in Software Development Lifecycle (SDLC).

At AmplifyBio, we’re committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization. Research shows that oftentimes women and minority groups only apply to open roles if they meet 100% of the listed criteria. AmplifyBio encourages everyone — including women, people of color, individuals with disabilities and those in the LGBTQIA+ community — to apply for our available positions, even if they don’t necessarily check every box on the job description. Hire for attitude and train for aptitude creates unique opportunities to build strong teams of smart, motivated individuals who love what they do.

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. AmplifyBio will not tolerate discrimination or harassment based on any of these characteristics. If you have a disability or special need that requires accommodation, please let us know during the recruiting process. We are committed to the safety and wellness of our employees and customers. Therefore, COVID vaccination is required.

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 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 an UNLIMITED PTO policy.
• Life and AD&D insurance
• Supplemental insurance
• LiveHealth Online
• Smart Shopper (helps you shop for better medical care and earn cash rewards while you save)
• 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.
• We are just getting started! More benefits on the way!
• An Opportunity to Change the World!!!