Compliance Scientist

Laboratory Applications and System SupportEvaluate systems, applications, and processes to ensure controls are in place to maintain security and integrity of data including adequate audit trail is established for data traceability.Ensure updates to equipment, methodologies, and processes are performed under approved change controls; perform change control assessments per user requirements.Investigation & Non-Conformance SupportParticipate in quality investigations to evaluate conformance to specifications, company procedures, and overall compliance to regulations.Ensure non-conformances are thoroughly investigated and appropriate corrective and preventive actions are implemented per established procedures and regulations.Ensure timely closure of Change Controls, CAPAs and quality actions, including effectiveness of corrective measures.Document & Process SupportDraft procedural documents to align processes across functions; develop and maintain local procedural documents in accordance with company and site policies and established regulations.Maintain processes and controls ensuring that performance and quality conform to established standardsEnsure procedural documents are reviewed and updated periodically per established timelines.Internal/External InspectionsAssist in preparation for internal and external inspections and audit, including compiling pre-requests.Metrics, Trends, & Continuous ImprovementsMonitor and trend compliance metrics, audit findings, process indicators, and compliance issues to improve quality systems and drive overall compliance.Inform/discuss with Compliance Lead potential risks and issues and/or opportunities for improvement and best practices to promote and strengthen commitment to compliance and safety.Participate in cross-functional team to ensure compliance measures are effectively implementedSupport SME for all compliance related issues and in collaboration with quality team.Perform tasks in compliance with all local, state and federal regulations and guidelines including but not limited to FDA, EMA, and OSHA; Comply with all company and site policies and procedures.This role will require 25% travel between client sites