Training Specialist

ThermoFisher Scientific; Allentown (Lehigh County); On-site; USD 60,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific is seeking an Operations Training Specialist to develop and deliver cGMP training for Operations staff in a manufacturing environment. You will create classroom and production-based modules, coach staff, and perform TCAs to ensure competency and compliance.

You will partner with cross-functional teams, maintain training records, and drive continuous improvement using PPIs. A Bachelor’s in Education or Adult Training and 2–5 years in pharma/cGMP is required; strong MS

Qualifications

• Bachelor’s Degree in Education/Adult training; 2–5 years in pharma or cGMP environment.
• Experience delivering training in classroom and production settings.
• Ability to coach, evaluate, and conduct TCAs.

Responsibilities

• Apply Good Manufacturing Principles in all areas.
• Deliver training for full-time and temporary staff in the cGMP environment.
• Develop classroom and e-learning training modules; instruct on SOPs and processes.
• Coach and evaluate to complete Task Competency Assessments (TCAs).
• Maintain training records and help achieve 100% compliance.
• Collaborate with cross-functional teams to plan, develop and implement training.

Skills

Training delivery

cGMP knowledge

Coaching

TCAs

PowerPoint

e-learning

MS Office

LMS

Education

Bachelor’s Degree in Education/Adult training

Tools

PowerPoint

Brainshark

Articulate

Job description

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

Job Description

When you are part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clients across the world. Whether planning, packaging, labeling, storing, or distributing important supplies, Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. http://www.fisherclinicalservices.com/

Location/Division Specific Information

CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.

How will you make an impact?

As part of our global team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer.

What will you do?

Our company seeks an Operations Training Specialist responsible for providing initial basic training for Operations employees in the cGMP environment. The individual will deploy training modules in both classroom and production environment settings and coaches/evaluates to complete Task Competency Assessments (TCAs). They will instruct in current Good Manufacturing Principles (cGMPs) and demonstrate and promote the company vision of the 4 I’s. The individual will work independently or as a part of a team in the completion of assigned tasks, often without constant supervision. They will provide intimate knowledge and rationale for all operational policies and procedures to trainees and supports cross-functional groups to establish course content and training objectives. They will serve as a role model leader, coach, and mentor and perform periodic on-the-floor Gemba walks to provide coaching support to Staff.

How will you get here?

• Bachelor’s Degree in Education/Adult training and/or 2-5 years’ experience in a pharmaceutical and/or cGMP environment.

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 – Intensity, Integrity, Innovation and Involvement
• 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 required to build high quality talent.
• Provides instructional design, training, and evaluation of effectiveness of training process.
• Creates classroom training modules in PowerPoint as well as e-Learning modules in applicable platform (e.g. Brainshark, Articulate, etc)
• Monitors employee training records, provides reports, and helps to achieve 100% compliance
• Drive continuous improvement and use of the Practical Process Improvement (PPI) Methodology
• Other duties may be assigned to meet business needs

Knowledge, Skills, Abilities

• 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.
• The ability to interact positively with a variety of skills sets and experience levels
• Computer proficiency in MS Office required. 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

Physical Requirements

• Individual needs to be able to carry the basic office equipment commonly used in this role, such as a laptop computer, projector, easel, a 20lb box of training materials, etc.
• 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 the max of 50 pounds occasionally (1%-49%)
• Must be able to bend occasionally (1%-49%)
• Must be able to squat occasionally (1%-49%)
• Must be able to 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 the right and left foot for repetitive action occasionally (1%-49%)
• Vision requirements for this position: close vision (clear vision at 20 inches or less), distance vision (clear vision at 20 feet or more), color vision, peripheral vision (ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point), depth perception (three-dimensional vision) and the ability to adjust focus
• Personal Protective Equipment Certification (PPE) including but not limited to filtering face masks, PAPR, N- 95 masks, half face masks and safety glasses are required to perform this position
• Position is responsible for teaching inspection of pharmaceutical products, components and labels. Incumbent must meet applicable visual acuity/color blindness standards to perform visual inspections in a cGMP environment.
• Must be able to work in both hot/cold occasionally (1%-49%)
• Will be exposed to moving equipment occasionally (1%-49%)
• Must be able to work in damp environment occasionally (1%-49%)
• Will be exposure to heights occasionally (1%-49%)

Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.