Monday & Friday work from home, Tuesday, Wednesday and Thursday - onsite) Key Responsibilities: 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document change management system, including change processing, organization of master documents, and archival of historical documents.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. Requirements: Education: bachelors degree in science or education 2-4 years experience in quality assurance or regulatory compliance in FDA regulated field. Minimum of 2 years experience in quality assurance training Experience using automated software training solutions Strong medical device background preferred
Job Type: Contract
Pay: $30.00 - $35.00 per hour
Schedule:
- Day shift
- Monday to Friday
Work setting:
Application Question(s):
- Please provide your email address!
Education:
Experience:
- Quality assurance, Regulatory compliance: 2 years (Preferred)
- Medical device: 4 years (Preferred)
- SABA Cornerstone Learning Mangement System: 1 year (Preferred)
Work Location: In person