Training Specialist

Location: Princeton, NJ - hybrid role - M&F work from home - Tues/Wed/Thurs- onsite in Princeton, NJ

Duration: 6 Months

Rate: $35/hr on W2

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 Management 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document change management system, including change processing, organization of master documents, and archival of historical documents.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.