<p>Job Summary</p> <p>Supports the lifecycle management of GxP computerized systems and supporting infrastructure to ensure compliance with applicable regulatory requirements and internal quality standards. The role partners with QA, QC, and Manufacturing to maintain compliant operation of GxP computerized systems.</p> <p>Responsibilities</p> <p>Computerized System Compliance:</p> <ul> <li>Support compliance activities for GxP computerized systems in accordance with 21 CFR Part 11, EU Annex 11, and GAMP 5. </li><li>Assist with lifecycle management activities including system implementation, validation, periodic review, and retirement. </li><li>Ensure systems maintain compliance with data integrity principles and internal quality policies. </li></ul> <p>IT Quality and Compliance Support:</p> <ul> <li>Assist with deviation investigations, CAPAs, change controls, and audit responses related to computerized systems. </li><li>Support regulatory inspections and internal audits involving computerized systems. </li><li>Develop and maintain documentation (SOPs, work instructions, related documents) in accordance with quality management system requirements. </li></ul> <p>Cross-Functional Collaboration:</p> <ul> <li>Partner within IT and externally with QA, QC, and Manufacturing to maintain system compliance. </li><li>Provide guidance on system configuration, security roles, and audit trail management. </li><li>Experience managing change and compliance for laboratory systems, process manufacturing systems, eQMS, ERP / PLM, and validated IT infrastructure. </li></ul> <p>Skills required</p> <ul> <li>Self-motivated, goal-oriented, and able to work with minimal supervision. </li><li>Excellent problem-solving skills required. </li></ul> <p>Education and experience</p> <ul> <li>4 to 6 years in regulated pharmaceutical, biotech, or medical device environments (or similar highly regulated environment.) </li><li>Strong knowledge of IT quality related subject areas. </li><li>Experience working within electronic quality management systems (eQMS). </li><li>Experience with computerized systems validation (CSV) and computer software assurance (CSA). </li><li>Excellent interpersonal and communication skills to facilitate interaction among employees at all levels. </li></ul> <p>Physical Requirements</p> <ul> <li>Prolonged periods of sitting at a desk and working on a computer </li><li>Potentially prolonged periods standing </li><li>Must be able to lift up to 15 pounds as needed </li><li>Must be willing to travel if needed </li></ul> <p>Compensation:</p> <ul> <li>$50/h commensurate with experience </li></ul>