ElevateBio is a cell and gene therapy technology company built to power the development of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies.
ElevateBio is looking for a contract to permanent Training Specialist, to join their growing Quality group. In this role the individual will provide support maintaining the Learning Management System (LMS) and coordinating the GxP Training program which are essential to ensure personnel are trained prior to performance. Will facilitate training activities in accordance with ElevateBio’s BaseCamp governing procedures, as well as in compliance with US and international regulations, laws, and guidelines.
Here’s What You’ll Do:
Under the guidance of the Manager, Quality Assurance the candidate will perform the following functions, but not limited to:
- Support Administration of the Learning Management System (LMS)
- Creation and assignment of training requirements to learners.
- Review completed training records, update LMS for completion, and archive records.
- Compile and report training metrics as requested.
- Support the GxP Training Program
- Identify issues and trends for system, procedure, and training improvements.
- Applies adult learning principles in delivery of new hire orientation training sessions.
- Collaborate with department leads to develop appropriate training curriculums, material and assessments to support execution of GxP activities.
- Support regulatory (i.e. FDA, EMA), inspections when necessary.
- Promote a Quality Culture by supporting innovation, teamwork and efficiency within the organization.
- Bachelor’s Degree and +5 years of experience with working QA in the pharmaceutical, biologics.
- Previous experience training adults preferred.
- Microsoft Word and Microsoft Access experience
- Knowledge of both domestic and international GMP and other relevant regulations.
- A team player, who listens effectively and invites response and discussion
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
- Strong facilitation skills for participant engagement and effective presentation skills
- Instructional design and curricula development experience preferred
Why join ElevateBio?
ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities.
At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.
Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.