Training Specialist 1

Posting Date 4 weeks ago(10/1/2021 12:32 PM)
Requisition ID
2021-9319
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Quality

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Training Specialist 1 at Cook MyoSite will work to identify, develop, and support the implementation of site and department training programs while ensuring consistency, compliance, and effectiveness within and across all departments.

Responsibilities

• Adhere to all guidelines related to training as established by regulatory authorities and company systems
• Develop, implement, and maintain training within the company
• Maintain training database and records management of all training materials
• Responsible for the development and delivery of applicable training sessions (OJTs, CAPA trainings, etc.), as warranted
• Ensure that trainings are relevant to the affected roles by assisting department with Job Code architecture
• Provide guidance to leadership regarding job codes
• Communicate incongruences in training to departmental management and provide recommendations for rectification
• Assist Departmental Trainers in scheduling and completing OJT tasks
• Review and complete all associated training forms/paperwork following GDP guidelines
• Maintain an open line of communication with the Training Department; attend inter-departmental meetings as needed
• Collaborate with and provide guidance to department Subject Matter Experts (SMEs) to develop/maintain position Training Plans
• Maintain Designated Trainer status
• Act as liaison for new hires
• Assist in conducting recurring GxP trainings
• Provide guidance to Change Control owner on the development of training material for Change Controls
• Review training material for Change Controls as needed

Qualifications

• Undergraduate degree in Life Sciences or Engineering or 6 years direct, relevant experience in a training or quality environment to provide a comparable background

• Minimum of 1-3 years experience in training atmosphere within Pharmaceutical/Biopharmaceutical or manufacturing is preferred

• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

• Knowledge of cGMP concepts and guidelines is preferred

• Must maintain company quality and safety standards
• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Trainability
• Must have effective verbal, written and interpersonal skills
• Must be a Cook Myosite Designated Trainer

 

Physical Requirements:

• Office Setting (no travel): General office, warehouse and laboratory setting.

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.

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