Senior Quality Training Specialist

Category:

Quality

Employment Type:

Contract

Reference:

BH-380010

Yoh is hiring for a Quality Training Specialist for our Pharmaceutical client in Noblesville, Indiana. This a great opportunity to join a growing team and share your knowledge within the industry.

Summary of Position
The Senior Quality Training Specialist position is responsible for the ownership, oversight, and execution of the site Training Program and ensuring compliance with applicable regulations. The position is responsible for ensuring the site's adherence to the site Training procedures, and managing assignments to ensure tasks are completed accurately and on schedule. The position requires frequent collaboration with site leaders and personnel across the site as the Senior Quality Training Specialist is the primary support and subject matter expert for Training.

Essential Functions

• Responsible for the site's Training program, maintaining associated procedures and Training materials, and ensuring compliance to regulations.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Regular collaboration with site leaders and personnel to ensure adherence to Training procedures. Assist area management with the creation of necessary Training items and Reports, such as the Department Curriculum Qualification Matrix.
• 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.
• Provide support during audits and regulatory inspections. Other duties, as assigned.

• Bachelor degree in Education, Instructional Design, Training Development, or Life Sciences required. Work experience is 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.