Training Specialist V (Manufacturing)

About the Company:

Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.

This position is responsible for training program execution for the Quality Systems Training Program for Merz personnel. Key responsibilities include: plan, design, implement and evaluate training initiatives for Merz employees and temporary personnel. The Senior Training Specialist will also work to ensure employee competence regarding all quality related topics along with developing a way to measure and continuously improve training effectiveness standards within Merz. This position requires a high degree of interaction with other Merz employees. Standard operating procedures provide guidance in performing the activities required.

Key Responsibilities:

Training Curriculum

• Responsible for training program execution for the Quality Systems Training Program for Merz personnel including employee on-boarding, initial and periodic competency delivery, and employee development.
• Including, but not limited to delivery of training and competency activities for manufacturing related tasks (aseptic techniques, gowning, mixing, filling etc.)
• Builds, designs, and delivers interactive training content, as well as stationary training content via PowerPoint, Word or other software.
• Develop, coach, mentor other Merz employees as needed to deliver effective training content.

Training Assignment

• Implements the training assignment, review, and documentation process for document change notice (DCN) function for Merz.

 DTC Program

• Support the Department Training Coordinator (DTC) program to ensure that DTCs are assigning job codes/ training plans effectively and in a timely manner for new and existing Merz personnel.
• Support and develop the Manufacturing Training Associate to create a sustainable training program for the Wisconsin Manufacturing sites.

Job codes/ Training plans

• Monitors the identification, development, implementation, and structure of job codes/ training plans for Merz required training.

Support training compliance

• Monitors organization-wide training compliance reports to ensure audit-readiness.

Support process improvement initiatives

• Drive continuous improvement initiatives/ projects for Quality Systems and functional training.

Support metrics

• Investigates training metrics trends to control and improve training processes and personnel performance.
• Investigates and resolves incidences of late training.

Support new training role orientation

• Design, implement and facilitate new training role orientation for Merz training leaders (managers, supervisors, DTCs, subject matter experts, qualified trainers, exam verifiers, etc.).

Supports Internal and Vendor Audit Functions

• Supports Internal and Vendor Audit Functions as needed.

Education:

• High School Diploma

Professional experience:

• Minimum 4 years related experience. Required.
• Adult Learning / Education / Training experience or certifications. Preferred

Knowledge, skills, and abilities:

• Understanding of manufacturing processes including, but not limited to, gowning, mixing, filling, and packaging.
• Knowledge of regulatory requirements for medical device / pharmaceutical organization.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio, and Access; Adobe; and Quality System Management Software.
• Computer skills in instructional design (e-learning) software (i.e., Articulate, Captivate, Articulate StoryLine).
• Management Systems (LIMS) and Quality Management software.
• Knowledge of quality systems, quality techniques, current regulatory requirements, and technical issues resolution.
• Proficient in FDA, European agency regulations, cGMP regulations.
• Adult learning and education.
• Familiarity with general GxP (Distribution, Documentation, Manufacturing, Laboratory, etc.).
• Highly effective communication skills. Ability to interact with organization wide employees at all levels.
• Handle confidential information with tact and discretion.
• Manage multiple priorities and work with interruptions.
• Strong technical and general problem-solving skills required.
• Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.

 

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) Manufacturing/Operations Generalist