Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

NON-NEGOTIABLE REQUIREMENTS:

• Bachelor’s degree and/or a minimum of 4+ years of experience as a Training Specialist or Technical Trainer or a similar role within a pharmaceutical, biopharma and/or biotech. manufacturing environment.
• Knowledge of the full training life cycle including adult learning principles and instructional design theory.
• Knowledge of current Food and Drug Administration (FDA) laws, regulations, practices, and guidelines.
• Experience implementing, administering, and maintaining electronic quality systems.
• Experience with Articulate or similar eLearning software.
• Proficient Microsoft Office Applications (PowerPoint, Word, Excel, Outlook, Visio).
• Technical writing expertise, strong facilitation, organizational skills, knowledge of GMPs required.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

PREFERRED REQUIREMENTS:

• Expertise in training programs for pharmaceutical industry is strongly preferred.
• Proficiency in use of MasterControl.
• Experience with instructional design for the development and delivery of effective classroom and computer- based training solutions.
• Prior experience working in a fast-paced, emerging growth CMO.

Responsibilities Include (but are not limited to):

• Manage and maintain users, course information, proficiency tests, and relevant documents in the Training Management System.
• Develop and revise training documents, materials & curricula in partnership with area management and site training department.
• Design and develop moderate to complex training eCourses by collaborating with SME’s.
• Evaluate effectiveness of training and development programs and utilizes relevant evaluation data to revise or recommend changes in instructional objectives and methods.
• Assist in analyzing and assessing training and development needs for individuals, departments and/or change controls.
• Lead Project management and continuous improvement initiatives related to the Training System.
• Provide insight on behalf of Training department on NCRs/DRs/CAPAs; serve as Training SME.
• Provide leadership to Training Coordinator to include coaching, critiquing, and motivating.
• Support internal, client, and external regulatory inspections by providing documents from the MasterControl DMS, including offsite searching, electronic and physical retrieval from vendor.

Full job description available during formal interview process.

• Manage and maintain users, course information, proficiency tests, and relevant documents in the Training Management System.
• Develop and revise training documents, materials & curricula in partnership with area management and site training department.
• Design and develop moderate to complex training eCourses by collaborating with SME’s.
• Evaluate effectiveness of training and development programs and utilizes relevant evaluation data to revise or recommend changes in instructional objectives and methods.
• Assist in analyzing and assessing training and development needs for individuals, departments and/or change controls.
• Lead Project management and continuous improvement initiatives related to the Training System.
• Provide insight on behalf of Training department on NCRs/DRs/CAPAs; serve as Training SME.
• Provide leadership to Training Coordinator to include coaching, critiquing, and motivating.
• Support internal, client, and external regulatory inspections by providing documents from the MasterControl DMS, including offsite searching, electronic and physical retrieval from vendor