Training Assistant

Posting Date 1 week ago(7/20/2021 3:01 PM)
Requisition ID
2021-9318
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 Assistant supports the training department with training, scheduling, and LMS activities and maintains compliance of organization with training data entry. This role is critical to the success of the training plan at Cook Myosite.

Responsibilities

• Manage the Learning Management System (LMS) to ensure compliance with SOPs
• Collaborate and support Training Specialist with the administration of the LMS
• Work with functional areas to ensure timely and accurate completion of required documentation
• Be the LMS subject matter expert to answer questions and determine solutions to challenges
• Support team projects
• Collaborate with Document Control to archive and manage paper records
• Enter, update, and assign training requirements through the LMS
• Ensure training forms are completed in compliance with all regulations and are entered into the LMS in a timely manner
• Assign learning to employee-based curriculum requests and maintain curriculum forms and other training documentation to ensure compliance with standard operating procedures
• Coordinate the logistics for all training
• Coordinate LMS activities, including maintaining system information, monitoring and tracking system info, and running/supplying reports on request
• Audit Learning Management System to ensure compliance with SOPs
• Leads and coordinate Change Controls with their associated DCRs to ensure training is connected with any updates or new training resources
• Assists in identifying/creating/developing/implementing/reviewing training based on audits, CAPAs, gaps, discussions
• Maintain and develop training courses and curricula
• Supports DCR/Change Control process with training consultation, training resource approvals and updates
• Work with managers to maintain compliance with anything training related
• Maintain awareness of company activities and events that affect training and compliance
• Develop and test LMS capabilities for the future development and implementation of training and documentation

Qualifications

• Associates degree in any field or 4 years of direct, relevant experience in training position to provide a comparable background

• Minimum of 1-3 years' experience in GMP training, manufacturing, or quality function

• 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

 

Physical Requirements:

• 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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