Information Systems Compliance Specialist
About the Job
Under minimal supervision, this position is responsible for reviewing quality systems and compliance in all areas of computerized medical devices and computer applications for Blood Systems and business units. This position serves as a resource to department and operations on computer-related quality and regulatory issues.
DUTIES AND RESPONSIBILITIES:
Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
Assures quality customer service to all customers.
Maintains good attendance and punctuality per the absence policy.
Participates in the development of IT related documents (i.e., SOPs, training, validations, test plans, matrices, software change control documents, etc.) and is responsible for review and approval of documents prior to implementation to ensure compliance to regulatory standards.
Supports internal audit team during audits of IT activities and assists with external IT inspections and vendor audits to include evaluation of observations and audit follow-up. Tracks IT deviations and performs follow-up to ensure corrective actions were implemented and effective.
Ensures compliance with computer related change control processes throughout projects to completion. Ensures adherence to documented design standards and conventions. Participates in the evaluation, review, and/or selection of computerized medical devices and computer applications.
Reviews testing activities to ensure quality results to include review of development of testing methodology, plans, and scripts as well as review of execution and performance of testing.
Participates on software change committees. Ensures system administration changes, application administration changes, processes, and procedures are handled in accordance with computer change control processes.
Consults with internal and external customers to support IT related compliance activities for Blood Systems and business units. Provides quality oversight for all aspects of information technology (i.e., manufacturing, HR, financials, etc.) and medical devices. Ensures computer systems and changes to computer systems meet required regulations across multiple operating units and divisions.
Reviews and approves all computer requested changes to ensure regulatory requirements are met. Reviews and assists in revisions to requirements, specifications, business processes, and recommendations related to proposed IT solutions.
Assists with support functions for QMRA applications, as needed.
Analyzes data to identify and monitor computer systems problem areas. Participates in Six Sigma and other performance improvement initiatives, as needed.
Remains abreast of changes and developments in the blood banking industry related to regulations and standards and provides direction to implement required changes. Establishes and maintains a network of professional relationships.
Performs all other duties, at the discretion of management, as assigned.
Bachelor's degree required.
Knowledge of computer environments, standards development, and system life cycle methodology required.
Knowledge of regulations as they relate to the blood industry quality and IT activities preferred.
IT related certifications (i.e., ITIL, COBIT, CISA, CSQE, etc.) preferred.
Four years of related experience in a regulated industry required. To include:
Two years of experience in IT quality, regulatory, and/or auditing.
Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.
Must be able to maintain confidentiality.
Must have analytical, statistical, personal organization, and problem solving skills.
Ability to work in a team environment and participate as an active team member.
Must have proficient computer skills.
Must have effective oral and written communication skills.
Ability to organize, prioritize, and execute a variable workload and multiple priorities.
Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail email@example.com or call 1-844-220-2612 to let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response.
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All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Company's established guidelines.