Quality Systems Specialist

CSV - Quality Systems Specialist Durham, NC up to $39/hr.

You will be responsible for:

Author and execute system and ERES assessments to evaluate data integrity and GxP compliance across computerized systems. Perform comprehensive assessments of GxP systems, identifying gaps against regulatory requirements and internal data integrity standards. Evaluate critical system controls, including audit trails, user access, electronic signatures, security configurations, and data retention practices. Support the development and execution of remediation plans to address data integrity and ERES compliance gaps. Collaborate cross-functionally with IT, Quality, Engineering, Manufacturing, Laboratories, and external vendors to ensure compliant system operations. Generate clear, concise assessment reports and summary documentation, effectively communicating findings, risks, and remediation strategies. Ensure adherence to project timelines, performance standards, and quality expectations, providing regular status updates to stakeholders. Respond to inquiries from management and end users, supporting ongoing compliance efforts and continuous improvement initiatives. About you : Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related discipline. 3-5+ years of experience in computer system validation (CSV) within pharmaceutical or other regulated industries. Strong knowledge of data integrity principles and regulatory requirements, including 21 CFR Part 11 and EU Annex 11. Experience authoring and executing validation deliverables and/or conducting ERES assessments in GxP environments. Familiarity with

GAMP 5, FDA

regulations, and industry best practices for computerized system compliance. Proven ability to support CSV projects, including assessment, validation, and remediation activities. Experience working in biologics or sterile manufacturing environments, with exposure to QC and manufacturing systems preferred. Excellent organizational, communication, and interpersonal skills, with the ability to manage multiple priorities in a fast-paced, matrixed environment 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