We’re seeking a IT Quality & Compliance Analyst for a 6 month W2 contract position for our award-winning, growing client in San Diego.
This person will interact with all tiers of staff and management and must possess quality, regulatory and IT knowledge. Listed responsibilities are essential and changes to individual responsibilities may occur due to business needs.
– Coordinates the Change Management process within the organization.
– Reviews system changes to provide compliance assessments and closure summaries that are audit ready.
– Operate independently to manage end to end compliance activities within projects.
– Develops and maintains software and hardware testing protocols (knowledge of different types of testing such as integration, unit, regression testing).
– Responsible for Validation Documentation.
– Participates in project and system requirements gathering/authoring; coordinates activities with business users and analysts.
– Strong oral and written skills to persuade, direct and advise stakeholders on regulatory compliance processes.
– Strong organizational skills to maintain and manage multiple validation projects
– Experience with enterprise applications such as SAP, LMS and EtQ.
– Experience with Validation Management Tools such as ValGenesis.
– Experience and leadership in fast-paced project implementations.
– Excellent customer service and communication skills.
– Experience with regulations and frameworks – e.g., 21 CFR Part 820/11, ISO 13485, SOX, HIPAA and GAMP.
– Experience with software development lifecycle activities, methodologies, testing and validation.
– Experience with common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS.
Please apply today!
For more information, please email: Jobfirstname.lastname@example.org.