Computer Systems Validation (Software Quality Assurance - CSV)

Computer Systems Validation (Software Quality Assurance - CSV) Durham, NC Long Term Contract rate to commensurate with experience Our client is a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries Due to our constant growth, we are looking for a SQA Lead Support to support our project in Lake Forest, IL. You will be responsible for: Software Quality Assurance with Review and Approval Experience for SDLC Deliverables Experience should have earlier in career in SDLC/Software Validation with writing and execution of SDLC deliverables (e.g. MVP, Risk) Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release). Several years of SQA experience with Review and Approval of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix and writing of System Certification) Support as SQA in the Review and Approval and implementation of regulated IT applications. Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met. About you: Strong Validation Resource with 15 yrs. Experience Responsibilities Previous experience with automated testing and implementation. Proficient in understanding of GxP regulations and validation principles Good experience in Review of CAPA's, Change Control and Defects as it applies to Software Validation Familiarity with a range of applications/tools including JIRA, Confluence, Client-ALM, Tosca, Confluence, Veera ,Qtest, M-Files, or other continuous integration tools Knows the difference between Waterfall and Agile software development methodologies Authorized to work in the United States for any employer or proper documentation if associated with a third-party agency Must pass background and reference checks Syndicus NACON provides service-oriented staffing and recruiting services to small businesses, large corporations, nonprofits, and government agencies. We pride ourselves on personal service, local market knowledge and commitment to providing great job opportunities. We specialize in contract, contract-to-hire, and direct placement positions. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #IND1