Manufacturing of cell therapy products.
The Manufacturing Training Associate is responsible for coordinating cGMP training initiatives within the Manufacturing Department, including the development and delivery of Manufacturing specific training content. Additionally, this position interfaces with the site Training Department to ensure department compliance with the Vericel GxP training system. The Manufacturing Training Associate also performs commercial cell therapy production-related tasks when required.
- Perform manufacturing procedures inside an ISO Class 7 (Class 10,000) cleanroom in accordance to established SOPs, cGMPs and safety regulations.
- Perform aseptic manipulations of applicable cell culture processes.
- Document production operations in corresponding batch records and log sheets according to CGMPs and established SOPs.
- Input data from production records to existing databases.
- Coordinate with Manufacturing Management to develop training plans, and provide feedback on training progress of individuals and the overall compliance level within the department.
- Assist Manufacturing Management with department cross training initiatives.
- Function as the Manufacturing Department liaison with the Training Department.
- Work with the Manufacturing team and Training Department to evaluate personnel training needs and participate in the development and delivery of Manufacturing training materials.
- Coordinate training plans for Manufacturing personnel to support base-business operations, encompassing training progression from observation through qualification.
- Work with the Production Planner to schedule training activities and the appropriate qualifications (e.g., Gowning, Aseptic Technique, etc.).
- Deliver and administer On-The-Job (OJT) training across multiple product lines in accordance with safety guidelines, cGMPs and SOPs.
- Monitor existing Manufacturing specific training programs, recommend improvements and support implementation.
- Participate in training projects with cross functional team members.
- Provide periodic training status reports to Management
- Responsible for maintaining the Training Lab to support training activities (e.g., sanitization, stocking, etc.).
- Act as subject matter expert (SME) for manufacturing processes in order to assist in reviewing and revising documents.
- Assists in deviation investigations, CAPAs, risk assessments and change controls.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all 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.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Bachelor’s degree (Life Sciences or related field) or equivalent with 2 years of experience with a solid cGMP background in Manufacturing and / or Quality positions.
- PowerPoint, Word, Excel and experience with database management and reporting.
- Previous experience developing and delivering training programs.
- Work independently under minimal supervision and direction.
- Ability to take on a leadership role within multiple teams.
- Strong verbal and communication skills.
- Ability to assist with project work that involves interactions with various departments and people.
- Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
- Learning Management System experience.
Working Conditions and Physical Demands:
- Flexibility in work schedule.
All qualified 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 Employer.