Sr. Document Control & Training Specialist (GMP)

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 Sr. Document Control & Training Specialist to join our growing team!!!

The Sr. Document Control & Training Specialist is a hands-on manager with experience leading document control and training programs in a new pharmaceutical GMP facility/environment.  This role maintains inspection readiness with focus on document and records management as well as training in alignment with Quality Objectives and GMP Requirements.

This is a unique opportunity to be part of an emerging organization bringing innovative technology to advanced therapies.

What You’ll Do Here:

  • Supervise employees, tasks and projects related to the document management and training systems.
  • Lead and continuously improve the document management system including routing of new, revised, and obsolete procedures, and document formatting according to established procedures via eQMS.
  • Manage all quality records for the site including archiving, storing, and retrieving records.
  • Manage the document periodic review process to ensure process owners evaluate and maintain procedures up to date.
  • Create and maintain document approval matrix to be used as baseline for document approvals.
  • Provide Good Documentation Practices overview and training as needed.
  • Oversee the training program and ensure compliance to regulations, procedures, and best industry practices.
  • Manage yearly GMP Training.
  • Work closely with department leads to create employee training plans including OJTs and lead the setup of site-specific training requirements for all employees.
  • Develop and report on KPIs / metrics for Document Control and Training programs.
  • Support the Quality Management System operation and compliance infrastructure as needed including but not limited to metrics reporting, quality management review, regulatory submissions, and inspection readiness.

We Would Love to Hear from You If:

  • Bachelor’s degree or higher in relevant biological sciences.
  • A minimum 5+ years of experience in both Quality and a GxP biotechnology or pharmaceutical environment with supervisory responsibilities.
  • Proficient experience managing an EMDS and LMS  
  • Experience developing and implementing a QMS for FDA-regulated pharmaceutical products.
  • Understanding through prior experience of GMP regulations and guidelines related to the conduct of early phase clinical programs under 21 CFR Part 210 and 211.  
  • Understanding of 21 CFR Part 11 Electronic Records and Electronic Signature guidance.
  • Strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem resolution skills. 
  • Ability to make decisions and recommendations related to the role.
  • Ability to work with minimal supervision
  • Highly goal-driven approach and the ability to focus on time-sensitive objectives. 

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 based on 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!!!

Apply Today!

Scaling science for life.