- Expiry Date: 20 August 2021
PURPOSE AND SCOPE OF POSITION:
The Senior Specialist, Instructional Design & Delivery will be responsible for supporting the Quality Systems Training team with the design and facilitation of training content. This position will be responsible for developing content related to GMP/GDP processes and procedures to ensure that compliance is established in accordance with company/industry requirements.
This role supports S12 operations.
This role is a member of the Quality Systems Organization.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Must have experience with cGMP manufacturing, Quality, and compliance.
Advanced understanding of instructional design software and electronic learning management systems.
Provide training/guidance to system users and in instructor-led settings.• Recognize and address quality opportunities to improve overall process/project efficiencies.
Able to prepare written communications and communicate problems to management with clarity and accuracy.
Comfortable providing input within the department and across the organization.
Completes routine tasks with no supervision.
Requires moderate direction to complete more complex tasks.
Recognizes risk for assigned project/processes and mitigates accordingly.
Propose solutions for complex issues and work with management to resolve.
Understand the basics of continuous improvement and improves efficiency and productivity within the group or project.
Recognize conflict and notify management with proposed recommendations for resolution.
Must be time organized and self-directed.
Forward thinking, seeking opportunities to positively impact the organization.
Able to support internal and health authority inspections of facility as required.
Education and Experience:
HS diploma or equivalent required.
College or university degree preferred.5 years of related Quality and/or Instructional Design experience in the pharmaceutical or related regulatory
An equivalent combination of education and experience may substitute
DUTIES AND RESPONSIBILITIES:
Proficient in training content creation and interviewing key stakeholders to develop specific training content to meet business needs. Design and produce engaging and adaptive learning solutions for GxP employees in a variety of formats, such as online, mobile, in-person and blended solutions.
Ability to visualize instructional graphics, the user interface and the finished product.
Analyze and apply trends and best practices in learning technologies and instructional design.
Provide exercises and activities to enhance the learning process.
Create supporting material/media (audio, video, simulations, role plays, games etc.) as required.
Devise modes of assessment within training, such as tests or quizzes, to measure the effectiveness of the course.
Strong authorship; able to write and critically review documentation for training purposes.
Consults with department management to develop department training programs and content.
Participates in the Quality System implementation process for upgrades and new system launches.
Works with Sr Manager, GMP Training on an on-going basis to prioritize training needs and to verify the effectiveness of cGMP training.
Demonstrates a general knowledge of Quality Systems, including but not limited to Change Control, Deviations/CAPA, Product Quality Complaints and Document Management.
Identifies, develops, and facilitates Annual GMP Refresher and Qualified Trainer programs.
Responsible for benchmarking within the industry to identify new content development software.
Serves as a backup for the LMS administrator as required.
Performs other duties as assigned.
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.