- Maintain a constant presence in the manufacturing area, ensuring production processes are monitored for compliance with site-wide SOPs.
- Verify daily that all manufacturing documents, training reports, and operators are approved and compliant with training before commencing operations.
- Review and audit training documentation and approved processes in TMS.
- Monitor the progress of the training programs to ensure they meet the actual operation in the field and provide feedback to QS Training on any changes that could be implemented to improve the process, e.g., skill maps or on-the-job training materials.
- Support the creation, development, and maintenance of training content/materials, including but not limited to on-the-job training aides, presentations, and documents as requested.
- Execute oversight of the training of manufacturing associates using other dedicated approved trainers from operations.
- Continually evaluate training materials for continuous improvement and use of good manufacturing practices.
- Conduct and document certification training of associates in groups or individually in a classroom or manufacturing setting.
- Evaluate and recommend improvements to the methods used for training content delivered to manufacturing associates.
- In collaboration with Manufacturing Management, other departments, and shifts:
- Schedule, coordinate, and initiate training sessions for manufacturing associates
- Ensure training is conducted in a consistent, effective, and efficient way.
- Create and revise standard operating procedures (SOPs), work instructions, controlled and other applicable documents for review with Manufacturing Management, Quality, and Engineering
- Provide timely and effective training to support identified Corrective and Preventative Actions.
- Assist with the optimization of each Value Stream process and documentation with a migration to a Manufacturing Execution System (MES) as a future state
- Monitor the process, manufacturing area, and environment for safe working conditions. Is empowered to stop any action that is deemed unsafe.
- Works with QS Training, Manufacturing Management, Quality, and Engineering to develop on-the-job skills qualifications program for manufacturing associates and OJT trainers
- Establish communication with new associates to ensure training is being conducted effectively, efficiently, and understood.
- Responsible for gaining and maintaining a working knowledge of all processes in the assigned Manufacturing Value Stream and maintaining the skills to train others.
- Conduct training, evaluate, and document all job/skills proficiency to ensure trainees can perform their job safely, efficiently, and to high-quality standards.
- Communicate issues with trainee competencies to Training Management and Manufacturing Management immediately. Any person or process identified as sub-standard shall be immediately brought forward, and actions stopped if deemed critical.
- Maintains all training records.
- Identify and assist in conducting cross-functional training between processes to maintain and improve the growth of associate knowledge and the flexibility of production to maintain the schedule.
- Deliver and display STOP reports to operators.
- Monitor training records to ensure GDPs.
- Maintain working knowledge of current Good Manufacturing Practices (cGMPs) and Good Documentation Practices
- Have the flexibility to support a 24/7 production environment.
- Support production projects such as inspections, 5S, CAPAs, time studies, etc
- Performs other related duties as assigned.
- Strong communication skills, Experience in conducting individualized and group training in a production environment.
- Proven ability to read, understand, and work with detailed visual aids such as method layouts, detailed diagrams, schematics, process flow sheets, related assembly documentation, and other documented practices.
- Possess strong organizational skills and attention to detail.
- Possess strong technical writing, problem-solving, and analytical skills.
- Knowledge of Lean Manufacturing methods.
- Must be able to work various shifts to provide training over multiple work shifts.
- Must be comfortable in delivering training to groups.
- Have the ability to recognize and adapt to changing priorities.
- Use Microsoft Word, Excel, PowerPoint, Access, and Outlook efficiently.
- Strong ability to communicate at all levels of the organization.
- Possess strong interpersonal skills with the ability to convey information to varying departments, shifts, and personalities.
- Demonstrate the ability to work as part of a cross-functional team.
- Must be able to stand/walk within and throughout the plant throughout an 8-hour shift.
- A high school diploma or equivalent. Associates Degree preferred.
- Four+ years of relevant experience in training coupled with three+ years of experience in a Manufacturing setting within an FDA-regulated industry.
- Experience in conducting individualized and group training required
- Having a working knowledge of Lean manufacturing and methodology is preferred.
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Sr Manufacturing Training Specialist - Elkton, United States - Terumo Medical Corporation
Description
Sr Manufacturing Training Specialist
Date
May 18, 2024
Req ID
2810
Location
Elkton, MD, US
Company
Terumo Medical Corporation
Department
Operations Training
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
Job Summary
The Manufacturing Training Specialist will support Manufacturing Management, Quality, and Engineering for overall compliance with the training program used by the Manufacturing Value Stream. The Manufacturing Training Specialist is responsible for ensuring all training materials are up to date and all manufacturing personnel comply with the training program before performing any job-specific tasks. In addition, the Manufacturing Training Specialist shall deliver operational-specific training, including on-the-job materials utilizing experience, established standard operating procedures, and skills. Furthermore, this position will support production projects as requested.
Job Details/Responsibilities
Job Responsibilities (continued)
Knowledge, Skills and Abilities (KSA)
Qualifications/ Background Experiences
It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.