Training Specialist

hybrid role - M&F work from home

Tues, Wed, Thurs- onsite in Princeton, NJ 08540

Normal business hours

$35.00/hr.-$40.00/hr.

Requirements :

• Education: bachelor’s degree in science or education

• 3-5 years' experience in quality assurance or regulatory compliance in FDA regulated field.

• Minimum of 4 years’ experience in quality assurance training

• Minimum of 3 years’ experience using automated software training solutions

• Strong medical device background preferred.

Knowledge of SABA Cornerstone Learning Mangement System is a plus.

• Administer the corporate training Learning Management System (LMS) to establish and document skill and procedural-based training for corporate employees. This includes assignment of employee training courses, tracking of course completion and confirmation that required training plans have been met to release new/revised process documentation.

• Ensure that the corporate quality system training practices, processes and systems comply with all applicable national and international regulations, including FDA Quality System Regulations (QSR, cGMPs) and ISO 13485:2016, European Medical Device Directive (MDD) and Regulation (MDR).

• Aide in the development, application, and maintenance of the corporate quality system training matrices requirements for roles within the corporate functional areas.

• Evaluate training curricula for sites and assist site personnel with their implementation of training programs and documentation practices.

• Identify best practices and process improvements for training identification, implementation, completion, and methods for evaluating training effectiveness.

• Work with Information Systems to identify and deploy system efficiencies in conjunction with process improvement.

• Assist in the administration of the corporate document change management system, including change processing, organization of master documents, and archival of historical documents.

• Review and manage change records to ensure the information is accurate and complete, including implementation strategies to fulfill training requirements.

• Promote and provide guidance in Good Documentation Practices.

• Collaborate with departments to ensure that all review activities are executed efficiently, effectively and in a timely manner.

• Support Record Management, Retention and Repository activities and processes.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.