eQMS System Administrator

Rochester Regional Health • Rochester, NY • 1d ago

Description Job Title: eQMS System AdministratorDepartment: QualityLocation: RemoteHours Per Week: 40Schedule: Monday - Friday, 9:00 AM - 5:00 PMSUMMARYAs an eQMS System Administrator for ACM Global Laboratories, the eQMS System Administrator is responsible for the development, implementation and ongoing continuous improvement of the company's electronic Quality Systems. In addition the eQMS System Administrator will interface with the business and functional leaders in Quality, Information Technology and Computer System Validation and other stakeholders to promote and support compliance.RESPONSIBILITIESServe as a resource promoting the development of understanding of the key elements related to electronic Quality Management Systems & regulatory compliance requirements including training opportunities to all staff at an organizational wide levelManage the promotion and assess the compliance with regulations, guidelines, policies and Standard Operating Procedures within the organization as it relates to the eQMSProvide support and key input to development groups for consultation & interpretation of regulations, guidelines, corporate standards & policiesProvide training support of electronic document control system related updates or features to global ACM users.Work independently or with small teams to manage routine eQMS activities.Serve as subject matter expert of eQMSIdentify and lead (as assigned) process improvements and initiatives to improve efficiency and effectiveness of eQMSMonitor, track and trend performance of processes within eQMSRecognize opportunities for improvements related to project objectives and apply sound judgement when addressing the issues.Independently generates solutions based on analytical skills and business knowledge.Support and is accountable for projects/programs that involve multi-functional teams.Provide systematic troubleshooting of failed processes or system software and/or technical issues reported by users; be able to quickly diagnose a problem and determine how best it can be fixed in the shortest amount of time with minimal disruption to users.Work with Business Owners to determine and recommend approach when eQMS system requires a software upgradeCollaborate with Business Owners to ensure upgrade programs/applications will match current hardware/software devices and meet business needs.Coordinate beta testing and system upgrades with Business Owners and EQMS.Evaluate system requirements (eQMS or computer needs) to determine potential enhancements or improvements to applications.Make provisions for planned IT maintenance outages; notify user community of system downtime; and provide coverage to IT maintenance team for eQMS system verification to allow for a system restart.Detailed conceptual knowledge/understanding of eQMS system operations and the planning for and responding to service outages and IT maintenance work.Evaluate and implement workflow and system changes per requests from Business OwnersManage system user profiles, permissions and roles in accordance with company policiesUtilize the change control system to support quality, consistency, and to protect the integrity of controlled documents, and perform periodic assessments of user access as required by standard operating procedures and regulatory standards and guidelines.Perform other duties as assignedREQUIRED QUALIFICATIONS2 years experience with system administration of MasterControl in a GxP environment.Bachelor's Degree and 1 Year of experience in a laboratory, pharmaceutical, medical device or clinical research organization OR 4 Years' experience in a laboratory, pharmaceutical, medical device or clinical research organization.PREFERRED QUALIFICATIONSEffective written and oral communication, technical writing and editing skills.Knowledge of and demonstrated experience in Quality, GCP, ISO15189, Proficiency Testing, CAP, CLIA, GLP.Experience working in and or managing an eQMS or eLMS system.PHYSICAL R

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