What are the responsibilities and job description for the GxP Training Specialist position at Minaris Regenerative Medicine?
At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.
The GxP Training Specialist reports to the GxP Training Manager and is responsible for supporting the implementation and execution of corporate quality training programs related to key compliance initiatives, applicable regulatory requirements, local and global processes, and the continuous improvement of compliance across Minaris RM facilities. The Training Specialist will partner with site personnel and Corporate Quality to ensure that Training and Continuous Education programs are properly maintained, implemented, and communicated across sites.
Essential Functions And Responsibilities
Business Support
Ensure through training that Minaris colleagues can succeed in precision-based processing/testing of cell-based products
Assist in the management of site training program(s) to ensure compliance with federal, state, and local regulations
Partner with site training representatives and SMEs from other disciplines to create, implement and harmonize processes and procedures
Support the Minaris Continuing Education system by providing support for continued improvement
Responding to all customer requests through the utilization of the department-specific mailbox
Provide Train the Trainers support for technique development for all production technicians that will support the dynamic nature of Minaris service offerings
Support GxP Training Manager on all facets of GxP Training
LMS Administration
Support and maintain the GxP compliance training system Veeva for employee and external resources across multiple locations
Manage general training curriculum for all Minaris personnel that ensures compliance with federal, state, and local regulations
Training Content
Managing GxP Training SharePoint site
Evaluate training needs and develop eLearning solutions through the application and utilization of various adult learning principles and eLearning technology tools
Qualifications
Bachelor’s Degree is required.
Six Sigma experience is a plus.
Veeva Vault Training experience is a plus.
Minimum of 2 years in a scientific/pharmaceutical setting.
Working knowledge of various authoring and eLearning development tools; i.e., Articulate Storyline, Adobe Captivate, Adobe Connect, PhotoShop, Lectora, Camtasia, Adobe Illustrator, Adobe After Effects, and/or Adobe Premiere.
Working knowledge of recording and editing audio and using eLearning development tools.
Ability to author, edit and review Standard Operating Procedures.
Self-motivated and able to work efficiently with minimal supervision.
Excellent communication skills, ability to work in a diverse, multi-cultural environment, detail-oriented, willingness to “roll up sleeves” and do the work required for success
Competencies/Candidate Profile
Adaptability, collaboration, can-do, accountable
Microsoft Office skills
Customer-focused
Effective communication and writing skills
Planning and organizing abilities
Quality Requirements
Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Attend all required Quality & Compliance training at the specified interval.
Minimum Required Training
N/A
Working Environment
Must have the ability to work in a team-oriented environment and with clients
This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. The noise level is moderate.
Must be able to work in an open floor plan environment and may work near others.
Physical Requirements
The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.
Sedentary work. Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. This role involves sitting most of the time utilizing desktop equipment for typing.
Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have sufficient vision to read materials.
Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.
Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.
Occasionally, ascends/descends a ladder to service lights.
Direct reports
N/A
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
Monday-Friday, Day Shift
The GxP Training Specialist reports to the GxP Training Manager and is responsible for supporting the implementation and execution of corporate quality training programs related to key compliance initiatives, applicable regulatory requirements, local and global processes, and the continuous improvement of compliance across Minaris RM facilities. The Training Specialist will partner with site personnel and Corporate Quality to ensure that Training and Continuous Education programs are properly maintained, implemented, and communicated across sites.
Essential Functions And Responsibilities
Business Support
Ensure through training that Minaris colleagues can succeed in precision-based processing/testing of cell-based products
Assist in the management of site training program(s) to ensure compliance with federal, state, and local regulations
Partner with site training representatives and SMEs from other disciplines to create, implement and harmonize processes and procedures
Support the Minaris Continuing Education system by providing support for continued improvement
Responding to all customer requests through the utilization of the department-specific mailbox
Provide Train the Trainers support for technique development for all production technicians that will support the dynamic nature of Minaris service offerings
Support GxP Training Manager on all facets of GxP Training
LMS Administration
Support and maintain the GxP compliance training system Veeva for employee and external resources across multiple locations
Manage general training curriculum for all Minaris personnel that ensures compliance with federal, state, and local regulations
Training Content
Managing GxP Training SharePoint site
Evaluate training needs and develop eLearning solutions through the application and utilization of various adult learning principles and eLearning technology tools
Qualifications
Bachelor’s Degree is required.
Six Sigma experience is a plus.
Veeva Vault Training experience is a plus.
Minimum of 2 years in a scientific/pharmaceutical setting.
Working knowledge of various authoring and eLearning development tools; i.e., Articulate Storyline, Adobe Captivate, Adobe Connect, PhotoShop, Lectora, Camtasia, Adobe Illustrator, Adobe After Effects, and/or Adobe Premiere.
Working knowledge of recording and editing audio and using eLearning development tools.
Ability to author, edit and review Standard Operating Procedures.
Self-motivated and able to work efficiently with minimal supervision.
Excellent communication skills, ability to work in a diverse, multi-cultural environment, detail-oriented, willingness to “roll up sleeves” and do the work required for success
Competencies/Candidate Profile
Adaptability, collaboration, can-do, accountable
Microsoft Office skills
Customer-focused
Effective communication and writing skills
Planning and organizing abilities
Quality Requirements
Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Attend all required Quality & Compliance training at the specified interval.
Minimum Required Training
N/A
Working Environment
Must have the ability to work in a team-oriented environment and with clients
This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. The noise level is moderate.
Must be able to work in an open floor plan environment and may work near others.
Physical Requirements
The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.
Sedentary work. Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. This role involves sitting most of the time utilizing desktop equipment for typing.
Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have sufficient vision to read materials.
Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.
Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.
Occasionally, ascends/descends a ladder to service lights.
Direct reports
N/A
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
Monday-Friday, Day Shift
Salary : $72,600 - $83,000
