Sr. Spclst., Learning & Development

Job Description

The Learning Senior Specialist supports the Wilson Learning and Development team as the point of contact for MDCP training and development that includes facilitating learning solutions through project management of new projects. This individual is responsible for the execution of the learning strategy by the implementation of the site capability plan to achieve the desired business results.

The Learning Senior Specialist should have a deep knowledge and understanding in the areas of learning, packaging operations, MDCPs (Medical Device Combination Products), QMS (Quality Management System) Topic 3.1, management of customized training state funded projects.

The Learning Senior Specialist drives and coordinates process improvement projects focused on training and qualification enhancements across the site.

PRIMARY ACTIVITIES                                                                        

Primary activities include, but are not limited to:

Training Strategy MDCP Capabilities

• Leads the Learning & Development organization to implement, maintain and continuously improve standard site processes: Job Skills & Qualification, SOP Process, Annual GMP, Customized Training Program,

• Partners with business to develop area capability plans linked to business requirements, inclusive of job, functional and leadership skills as well as development of team capabilities.

• Responsible for building forward looking capabilities for the Wilson Site for training and qualification solutions to close performance gaps and to ensure employees are positioned for success.

• Identifies need for new training solutions and methods.

• Conducts external benchmarking as a mechanism to evolve learning and development in Wilson.

Quality Management Systems, Audits & Inspections, Compliance

• Coordinates the authoring of QMS Topic 3.1 Training and Qualification annual health assessment and is consulted as a subject matter expert for the topic.

• Understands and manages compliance documentation to ensure compliance to internal and external regulatory standards.

• Responsible to ensure that training is accurately recorded in training records and that all training in compliance with procedures relevant to the role/activity.

• Identifies quality-related trends and facilitates implementation of corrective actions.

• Leads and supports the organization in Permanent Inspection Readiness and cGMP Compliance.

• Ensures Safety and Quality policies and guidelines are followed by all colleagues within the Learning & Development function.  Responsible for bringing to the attention of management any violation in cGMPs and/or other concerns which may affect the safety of People or the safety of product; efficacy, or purity of our company's product.

• Responsible for compliance of the LSS standards (MyLearning Standards).

• Responsible to ensure that training is accurately recorded in training records and that all training in compliance with procedures relevant to the role/activity.

• Ensures adherence to all Learning & Development policies and processes from site, Learning and Global.

• Collaborates with Learning, Learning Support Services and other Manufacturing Divisi sites to leverage best practices.

• Contributes to the management and improvement of the enterprise-wide Learning Management System (LMS).

• Coaches Subject Matter Experts and Trainers for learning programs.

• Facilitates and delivers assigned routine training as required. Troubleshoots training & qualification problems.

• Facilitates problem solving and identifies short-term and long-term actions to prevent problem reoccurrence.

Customized Training Program

• Plans, Manages, and Implements the Customized Training Program for our Wilson site

• Partners with North Carolina Customized Training Program Director and Wilson Community College Director of Workforce Development to procure the funding for the program, track the budget of the program, and schedule courses for the Wilson site personnel eligible for the program.

SKILLS

Education Requirements

• Bachelor's Degree Required

Required Skills

• A minimum of 5 years of experience in Learning and Development

Preferred Skills

• High Level of Knowledge of Pharmaceutical Operations E2E Business Process & Functions

• Quality Management systems, cGMP, and regulatory inspections