Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing training professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Senior Director, Corporate Information System at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.
This department manages the Vericel training system. They develop, manage, and support training programs within the company to meet GxP regulations, internal processes and standards, and to develop the skill set of all employees.
Responsible for the design, maintenance, and administration of the training Learning Management System (primarily electronic with some paper-based elements). This position is responsible for establishing and implementing the strategy for maintaining training requirements and curricula by ensuring training documentation is completed, processed, filed, and archived in accordance with GxP and Vericel standards. May deliver specific GxP, New Hire Orientation and other related training material as needed.
Serve as Training Learning Management System Administrator by establishing, managing, and continually improving strategy for GxP compliance (35%):
- Manage the LMS system (ComplianceWire).
- Provide training system and LMS support to functional areas and Training personnel.
- Represent training department during internal and external regulatory audits and provide LMS support as necessary.
- Develop, maintain, and provide training on Vericel LMS to applicable personnel.
- Maintain process for training record data entry, filing, archival, and retrieval.
- Actively research and analyze industry learning technology trends and determine applicability to the Vericel training system.
- Other duties as assigned.
Provide Training LMS and Logistical Support (30%):
- Act as an LMS coordinator and provide LMS reports as necessary.
- Process training data (training records, curricula updates) in the LMS in a timely fashion and file accordingly.
- Address general training system and LMS inquiries, including (but not limited to): confirming training status, process for establishing/editing curricula, prerequisite requirements for training, etc.
- Assist with delivery/training setup for SMEs delivering training (WebEx, presentations, etc.).
- Coordinate with New Hire Orientation stakeholders and schedule personnel for new employee training.
- Work with owning departments and qualified trainers to schedule instructor-led training sessions.
- On occasion, assist functional areas with scheduling personnel for the appropriate qualifications such as gowning, aseptic technique, foreign matter, etc.
Develop and deliver training programs, as needed (15%):
- Work with the training team and collaborate with functional area management and SMEs to design, develop, approve, and maintain training curricula and training materials in a GxP environment.
- Partner with document authors and process owners to establish training approach for functional area procedures and processes by performing needs analysis.
- Evaluate existing training programs and improves training solutions, where applicable.
- Exercise sound judgment in determining method of trainee evaluation and qualification on specific tasks or activities.
Establish, maintain, and generate site training metrics and LMS reports focusing on agreed upon KPIs (10%):
- Work with senior leadership and functional area management to establish Key Performance Indicators for the training system.
- Generate and present/provide training metrics as needed.
- Partner with functional areas to address identified training compliance gaps.
Partner w/functional areas to conduct training effectiveness checks and trending of results (10%):
- Establish mechanism for assessing the effectiveness of training programs (ILT, OJT, E-Learning) using Kirkpatrick's Levels of Evaluation.
- Track and trend effectiveness of programs, and work with other Training Department personnel to provide recommendation to area management to improve training programs.
- Manage course evaluations and other training effectives tools.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
Required Education and Experience:
- Bachelor’s degree and 3+ years relevant experience in a GxP Training environment involving the maintenance of a Learning Management System.
- Prior Learning Management System experience with an emphasis on design and maintenance. Familiarity of ComplianceWire LMS preferred.
- Must be customer-focused and service-oriented with effective communication skills.
- Works independently and efficiently with minimal supervision/guidance.
- Proficient with Microsoft Word, Excel, Visio.
- Organizational and time management skills, ability to multi-task while still meeting deliverables.
- Project management skills with an ability to take on leadership roles.
- Technical writing experience (i.e. development of SOP and/or OJTs).
WORKING CONDITIONS AND PHYSICAL DEMANDS
- May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.