Training Specialist
Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain services. With a focus on service, science, and process engineering, we are exclusively dedicated to serving the packaging and distribution requirements of clients worldwide. Our work ensures adherence to the highest standards of quality, performance, reliability, and sustainability.
About the role
As an Operations Training Specialist, you will provide initial basic training for Operations employees in a cGMP environment. You will deploy training modules in both classroom and production settings, coach and evaluate employees to complete Task Competency Assessments (TCAs), and instruct in current Good Manufacturing Principles (cGMPs). You will demonstrate and promote the company vision of the 4 I’s (Intensity, Integrity, Innovation, and Involvement) while serving as a role model, coach, and mentor.
Responsibilities
- Applies Good Manufacturing Principles in all areas of responsibility.
- Conducts all activities in a safe and efficient manner.
- Demonstrates and promotes the company vision through embodiment of Thermo Fisher’s 4 I’s.
- Serves as a Role Model Leader, Coach, and Mentor.
- Provides initial basic training for full-time and temporary employees in the cGMP environment.
- Deploys training modules in both classroom and production environment settings and coaches/evaluates to complete Task Competency Assessments (TCAs).
- Provides intimate knowledge and rationale for all operational policies and procedures to trainees.
- Collaborates with cross-functional or cross-site teams to plan, develop, coordinate, and implement training on company SOPs, processes, and related proficiencies.
- Provides instructional design, training, and evaluation of the effectiveness of the training process.
- Creates classroom training modules in PowerPoint as well as e-Learning modules in applicable platforms (e.g., Brainshark, Articulate).
- Monitors employee training records, provides reports, and helps achieve 100% compliance.
- Drives continuous improvement and use of the Practical Process Improvement (PPI) Methodology.
- Performs periodic on-the-floor Gemba walks to provide coaching support to staff.
- Other duties may be assigned to meet business needs.
Requirements
- Bachelor’s Degree in Education/Adult training and/or 2-5 years’ experience in a pharmaceutical and/or cGMP environment.
- Able to read and thoroughly understand process-specific and technical procedures.
- Detailed knowledge and understanding of processes and procedures.
- Possess keen attention to detail.
- Able to comfortably explain processes to new employees up to all levels of management.
- Comfortable enforcing process compliance and adherence to site/department policies.
- Possess sound training and coaching skills.
- Able to communicate complicated procedures in an easily understood manner.
- Career track and/or accomplishments should demonstrate a passion/successful track record of training.
- Coach/evaluator trained and/or Master Trainer Certification preferred.
- Must maintain high ethical standards to support a professional business code of conduct.
- Computer proficiency in MS Office required; experience with Learning Management Systems, video, and audio.
- Experience preparing training materials and performing training for large groups of hourly technicians (new and veteran), as well as individual coaching as necessary.
- Ability to coach and facilitate teams.
Skills
- Ability to work independently or as part of a team, often without constant supervision.
- Strong interpersonal skills to interact positively with a variety of skill sets and experience levels.
Environmental Conditions
- Adherence to all Good Manufacturing Practices (GMP) and Safety Standards.
- Exposure to cold rooms/freezers (-22°F/-6°C).
- Required use of Personal Protective Equipment (PPE) including safety glasses, gowning, gloves, lab coat, ear plugs, etc.
- Warehouse environment with occasional exposure to moving equipment, damp conditions, heights, and hot/cold temperatures.
- Must meet applicable visual acuity/color blindness standards for inspecting pharmaceutical products, components, and labels in a cGMP environment.
- Certification in Personal Protective Equipment (PPE) including filtering face masks, PAPR, N-95 masks, half face masks, and safety glasses.
Physical Requirements
- Must be able to carry basic office equipment such as a laptop computer, projector, easel, or a 20lb box of training materials.
- Must be able to stand continuously (95%-100%).
- Must be able to walk frequently (50%-79%).
- Must be able to sit (up to 49%).
- Must be able to lift and/or carry up to 50 pounds occasionally (1%-49%).
- Must be able to bend, squat, and reach above shoulder level occasionally (1%-49%).
- Must be able to use both right and left hand for repetitive action, simple grasping, pushing and pulling, and fine manipulation occasionally (1%-49%).
- Must be able to use both right and left foot for repetitive action occasionally (1%-49%).
- Vision requirements: close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.