Quality Training Program Manager
4 days ago
At Yoh, a leading staffing agency, we are seeking an experienced Senior Quality Training Specialist to join our team in Noblesville, Indiana. This is a unique opportunity for a skilled professional to make a meaningful impact in the pharmaceutical industry.
About the Role:
Job Summary:
The Senior Quality Training Specialist will be responsible for overseeing and executing the site's Training Program, ensuring compliance with applicable regulations and guidelines. This includes maintaining operational compliance with US and international regulatory agencies and guidelines, regular collaboration with site leaders and personnel, and providing Training guidance and coaching to site personnel. The ideal candidate will have experience with various Training tracking metrics, instructional design, and electronic Learning Management Systems.
Key Responsibilities:
• Develop and execute the site's Training Program, ensuring compliance with applicable regulations and guidelines
• Maintain operational compliance with US and international regulatory agencies and guidelines
• Regular collaboration with site leaders and personnel to ensure adherence to Training procedures
• Provide Training guidance and coaching to site personnel, including primary contact for Training inquiries
• Develop and conduct identified Training courses for site personnel
• Daily collection, entry, and filing of Training forms
• Maintenance of personnel Training folders and completed Training forms, ensuring proper retention and retrieval of Training records, as necessary
• Facilitate periodic review of Training documents for accuracy and relevance, and ensure completion of reviews
• Perform Training functional review of Change Controls, assessing risk and impact of proposed changes in relation to Training requirements
• Coordinate annual GMP Training, and other assigned training courses for the site
• Assemble, analyze, and report metrics on the state of the Training Program to ensure regulatory compliance, identify trends, and areas of improvement on a routine basis to management
• Develop and execute continuous improvement efforts, according to project plans and timelines, for identified projects
• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and standard operating procedures
Requirements:
• Bachelor degree in Education, Instructional Design, Training Development, or Life Sciences required; work experience considered in lieu of degree
• 5 or more years of relevant experience required managing Training projects, including timelines, resources, and deliverables
• Must have experience with various Training tracking metrics, including identification, use, interpretation, trend identification/analysis, and presentation
• Must have experience with instructional design and assessment configuration; experience developing training media and computer-based training design and development preferred
• Must have experience with electronic Learning Management Systems, ComplianceWire preferred
• Must be thoroughly familiar with applicable regulatory requirements and guidelines concerning the manufacture of finished pharmaceutical product and the associated supporting functions as it relates to Training
• Must have a working knowledge of cGMP guidelines and their application in a controlled aseptic environment
• Must have experience with statistical tools and be proficient in use of Microsoft suite of products, and Quality Management Systems applications
• Must possess strong problem-solving and decision-making skills
• Must possess strong verbal and written communication, organization, and time management skills
• Must be results-oriented, able to make decisions, and prioritize work per business needs in a fast-paced dynamic environment
• Must have ability to exercise independent judgment in planning, organizing, and performing tasks
• Must have ability to communicate, motivate, and organize projects among a broad spectrum of personnel throughout the network, frequently under deadline pressure
Estimated Salary:
$75,000 - $100,000 per year
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