3 Audit Coordinator Jobs

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Quality Audit Coordinator serves as the central point for all sponsor, regulatory, supplier, and internal audits across the company s eClinical solutions. The role safeguards continuous inspection readiness by organizing evidence, managing logistics before, during, and after each audit, and collaborating with departments across the entire Organization. Success is measured by complete and accurate audit files, on-time CAPA closure, and ongoing process improvements that streamline future inspections. KEY TASKS & RESPONSIBILITIES Pre-audit coordination assists with scheduling audits, confirm audit scope, assembles document packages, schedule interviews with subject-matter experts, and prepare on-site or virtual audit rooms. Live audit support serve as primary scribe, manage real-time document requests, track question/response logs, and controls the flow of materials to auditors. Post-audit follow-up compile meeting minutes, distribute observation summaries, assists in maintaining a findings tracker, and coordinate timely CAPA responses with owners. Maintain audit documentation keep electronic folders and QMS trackers current, version-controlled, and compliant with retention requirements. Support internal quality audits schedule, prepare, and close routine internal audits. Capture and verify records document audit interviews accurately and circulate for stakeholder confirmation. Facilitate cross-functional readiness ensure the various business units have evidence and answers prepared in advance. Assist with vendor audits assist with coordinating assessments of third-party eClinical service providers and monitor follow-up actions. Improve audit processes recommend and implement tools or workflow changes that reduce audit-prep time and strengthen documentation integrity. Update SOPs and work instructions related to audit management and inspection readiness. Perform additional duties as assigned to enhance the Quality Management System and maintain continuous inspection readiness. Education & Experience Bachelor s degree in a related field is preferred 3-5 years of experience working in a pharmaceutical industry is preferred. Knowledge of clinical trial terminology and process. Knowledge of GxP quality standards, applicable regulations, and software development risks. Professional Skills Professionalism, confidentiality, and organization. Excellent writing and typing skills. High level of organizational skills and record-keeping. Ability to work effectively under critical deadlines. Robust communication skills and attention to detail. Technical Skills Ability to pull reports or extract data when needed. Ability to easily learn various software applications. Experience with Qualio or other type of QMS tool Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. Job Description Roles and Responsibilities Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Assess changes in regulations and global QMS , develop and implement QMS implementation plans. Maintain site QMS including procedures, Work instructions and templates for Manufacturing and Design scope Manage Internal Audit program including planning, execution and closure by identifying audit team and leading them Conduct Quality Management reviews and ensure the Quality Management system is effective and efficient Required Qualifications Role requires advanced experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience). Working Knowledge on ISO13485 standard and Medical device regulations Skilled in Program Management methodologies Efficient in communication Desired Characteristics Working experience in Medical Device industry Prior experience in managing Quality Management System including Quality manual, Procedures and Work instructions Prior Internal Audit experience as Auditor/lead Auditor/Audit coordinator Skilled In Influencing skills and conflict management methodologies

Job Summary: The Audit Scheduler is responsible for efficiently planning, coordinating, and scheduling audits by liaising with auditors, clients, and internal teams. This role ensures that all audits are scheduled in a timely manner, resources are optimally utilized, and compliance with program and client requirements is maintained. Key Responsibilities: Audit Planning & Scheduling: Develop and maintain the audit schedule based on client req uests, auditor availability, and program requirements. Coordinate with auditors to ensure appropriate allocation and timely completion of audits. Communicate with coordinators, clients and facilities in some cased to confirm audit dates and logistical details. Manage last-minute schedule changes, cancellations, or rescheduling requests. Coordinate with Travel desk / admin team and facilitate auditors travel arrangements (Road, Rail, Air travel bookings) Coordination & Communication: Act as the primary point of contact between auditors, clients, and internal stakeholders for scheduling matters. Ensure auditors receive all necessary details regarding assigned audits, including scope, location, and special requirements. Address scheduling conflicts and work towards effective resolutions. System & Database Management: Maintain audit scheduling records in internal databases or scheduling software. Ensure all audit details are accurately updated and documented. Generate reports on audit scheduling metrics, including efficiency and utilization. Compliance & Process Adherence: Ensure scheduling practices comply with company policies and client-specific requirements. Support the audit team by ensuring adherence to turnaround time (TAT) commitments. Assist in continuous improvement initiatives for scheduling efficiency. Qualifications & Skills: Bachelor's degree in Business Administration, Operations Management, or a related field (preferred). Experience in audit scheduling, operations coordination, or administrative roles. Strong organizational and time-management skills. Excellent communication and interpersonal skills. Proficiency in Microsoft Office (Excel, Word, Outlook) and scheduling software. Ability to multitask and work in a fast-paced environment. Preferred Skills: Experience in compliance, audit, or certification industry scheduling. Familiarity with audit-related software or ERP systems. Problem-solving mindset with a focus on process improvement