Quality & Training Specialist


Virtual / Travel

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 32 days ago

  by    Jitendra Kushwah

Ensures that training/education programs and course materials are current and accurate. Responds to inquiries from other departments regarding training requirements and recommendations. Manages system training environment in coordination with IT and vendor partners (e.g. super user requests for training environment access, refreshing of training environment, ad hoc system training delivery).

Job Responsibilities:

Provides instructional design in creating, delivering, and maintaining instructor led and eLearning training programs in support of training initiatives and educational programs. Creates training plans. Gains adequate understanding and knowledge of the training content. Develops training announcements and confirms training audiences when developing training materials. Evaluates feedback and evaluation data from training programs and makes recommendations for changes to materials. Conducts Lessons Learned post training. Keep current with industry practices as well as GCP regulations/policies. Follows all standard operating procedures as required by the position. Performs other duties as assigned by department leadership. Project management. Liaison with clients, process owners, business owners, quality monitoring and compliance liaison for SOP developers to ensure that training needs are discussed and addressed. Manages system training environments in collaboration with IT partners.

Required Education & Experience:

A 4-yeardegree in Education, Instructional Design, Life Sciences, or Communication, or an equivalent of experience. A Senior Specialist requires a minimum of four years of related experience designing and developing instructor-led training/educational programs in a corporate setting or a minimum of six years in the Pharma industry in general.

Required Skills:

Working knowledge of adult learning theory and sound instructional design principles. Working knowledge of how to design, develop and deliver instructor-led training sessions for maximum impact and retention. Working knowledge of ICH Guidelines; familiar with FDA regulations and the EU Clinical Trial Directive preferred but not required. Familiar with learning evaluation strategies and how to apply them to an education program. Good understanding of client's business processes and practices. Good understanding of LMS/learning portal functionalities and capabilities. Project management. Working knowledge of Microsoft Office (Word, PowerPoint, Excel) and Turning Point Audience Response System. Written and spoken proficiency of the English language is required. Operates in a team environment. Stays current with industry trends with respect to adult learning theory, learning practices and methodologies. Time Management. Excellent written and oral communication skills. Presentation skills. Ability to transfer knowledge.

This resource's primary role will be to learn the Veeva Vault Study Startup and eTMF applications in order to manage our system training environment and deliver ad-hoc training to end users. We will be deploying the system broadly to the organization. Team is creating training materials; this individual will partner with our client training group to coordinate updates to training materials moving forward and translate that into hands-on system training sessions for our end user community. This individual will spend a good majority of their time in the system and joining my team in change management activities to demo the system. Proficiency in Veeva Vault is an asset. Individual must be technically proficient and able to learn and understand the system in order to help drive adoption.