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Training and Compliance Specialist

Company: SDC (Statistics & Data Corporation)
Location: Tempe
Posted on: February 22, 2021

Job Description:

Job SummaryThis role will report within the Quality Assurance department at SDC and will be responsible for the overall administration, execution, management, and maintenance of the training system and program. This role will also be responsible for ensuring compliance with applicable Good Clinical Practices (GCP) and regulatory requirements through company policies, processes, and procedures (Standard Operating Procedures (SOP)). This role will be expected to monitor and review quality trends both internally within SDC and externally through review of changes to regulatory compliance and ensure SDC staff is adequately trained to meet these internal and external requirements.Primary Responsibilities* Management, continual assessment, and improvement of the training system at SDC and ensuring compliance with GCP and applicable regulatory requirements* Assist with the development and maintenance of the onboarding training process by establishing, tracking, and measuring new hire training programs for effectiveness* Management of ongoing training and education of the SDC staff by the development and presentation of training courses based on analysis of internal SOP changes and external regulatory changes* Develop training program for select SDC staff to assist with administration of departmental specific training (Train the Trainer approach)* Develop and monitor appropriate metrics to ascertain the effectiveness of the training programs and trainings administered to the organization* Drive awareness and compliance with applicable standard operating procedures/regulations to meet, comply and champion all quality and regulatory commitments of SDC* Solicit feedback and collaborate cross-functionally across SDC as needed to evaluate quality trends and recommend improvements through SOP modifications and/or training* Participate in the internal audit program, including conducting internal audits* Maintain relevant knowledge of both local and international regulations and appropriate GCP requirements and developments as they impact SD'Cs SOPs and compliance* Adherence to all components of SDCs quality system* Assist with tracking and monitoring internal and external feedback to drive accountability and continuous improvement at SDC* Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirementsThe above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.Required Skills* Excellent interpersonal, verbal, and written communication skills, including experience in making presentations and delivering trainings to various audience sizes and levels* Experience with Microsoft based applications and ability to learn internal systems* Willingness to work effectively with multiple departments/managers in a matrix environment and to value the importance of teamwork and collaboration* Strong ability to motivate company personnel to adhere to quality processes and procedures* Experience with implementing, maintaining, and enhancing training programs as well as experience with Train the Trainer approach to training development* Experience with electronic training management systems is strongly desired* Experience with auditing (internal preferred) is strongly desired* Strong attention to detail with a customer focused approach* Analytical focus with a continuous improvement approach Experience working within regulated industries with a preference for knowledge and understanding of GCP,* 21 CFR Part 11, and other applicable regulatory requirementsEducation Or Equivalent Experience* Bachelor's degree (preferably in engineering, applied or life science) and at least three (3) years of experience with training, compliance, or quality assurance in a regulated industry

Keywords: SDC (Statistics & Data Corporation), Tempe , Training and Compliance Specialist, Other , Tempe, Arizona

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