Job Description Summary

Job Description

Job Description

Develop, implement, and administrate the Training system in achieving manufacturing, production, and quality goals. Responsible for motivating and supporting associates in achieving training targets. Ensure production associates are properly trained and resourced with necessary training materials. Training system will include an effective cross-training program to improve manufacturing flexibility. Excellent communication and time management are required as this person will create training documentation, conduct training, facilitate meetings, and administrate the training system.

Responsibilities:

• Assist in the development and implementation of a site integrated training program in compliance with GMP principles and regulatory agency requirements.

• Supports facility’s Continuous Improvement program to reduce cost, cycle time, improve quality and/or increase throughput through effective training program.

• Collects all relevant data needed to analyze a complex problem, situation or issue related to training.

• Provide training to new employees.

• Coordinate specialized trainings and certification/re-certification program.

• Develop training program procedures documentation system.

• Develop training materials (Videos, Power Point slides, handouts, etc.)

• Update and expand new training modules based on modern industry practices and regulations.

• Establish training performance metrics to track and communicate effectiveness of the site training program. Calculates and communicates the impact of training through the key operating metrics, turnover, and associate satisfaction.

• Assist in internal and external audits.

• Responsible for the documentation of training in C2C.

• Records and maintains all necessary certifications, as per Training system requirements.

• Identifies/implements processes to resolve gaps in training, development, and recertification.

• Actively evaluates and improves training methodologies (train the trainer).

• Responsible for updating the department training matrix.

• Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.

• Other duties as assigned.

• Constant process improvements using Continuous Improvement principles and tools, such as Kaizens, Standard Work, etc.

• Manage resources to ensure optimal output with minimum overtime.

• Ensure that training materials, such as standard work instructions are updated.

Requirements

Knowledge:

• Experience in FDA, GMPs and ISO requirements.

• Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements.

• Project Management, ISO 13485, Quality System Regulation 21 CFR 820.

• Working knowledge of Training Systems in a regulated environment.

Skills:

• Computer proficiency in Microsoft office (Word, Excel, Power Point, Project, Outlook).

• Strong project management skills.

• Excellence in problem solving.

• Good team player skills.

• Excellent written and oral communication skills as well as organizational capabilities.

• Strong collaboration and team building skills

• Experience in Lean/Six Sigma preferred.

• Demonstrates some influence within a work area/department/function. Accomplishes tasks mainly through coaching and supervision.

Education/Experience:

• BS required, preferably in engineering, scientific or health-related discipline.

• 2 years of experience facilitating/developing training programs in a manufacturing/technical setting

• 2 years relevant experience as direct Supervisor.

PDN

Primary Work Location

Additional Locations

Work Shift