IT QA Lead

United Consulting Hub delivers specialized validation and quality solutions across the life sciences industry, supporting clients with Computer Systems Validation, Equipment & Process Validation, QA, QC, Microbiology, and Regulatory Affairs. Job Description We are seeking an experienced IT Quality Assurance Specialist / Lead to support GxP computerized systems and IT compliance within a pharmaceutical manufacturing environment. The role will provide quality oversight across validation, data integrity, change control, deviations, CAPA, audits, and system lifecycle activities. Position: IT Quality Assurance Specialist / Lead Industry: Pharmaceutical Manufacturing Location: NJ Key Experience 5–10 years of experience in IT QA, CSV, CSA, or GxP IT Compliance Pharmaceutical, biotech, medical device, or regulated life-sciences experience Strong experience with Computerized System Validation (CSV) and Computer Software Assurance (CSA) Knowledge of GAMP 5, FDA 21 CFR Part 11, 210/211, EU GMP Annex 11, ICH Q9/Q10, and ALCOA+ Experience reviewing URS, validation plans, risk assessments, FS/DS, IQ/OQ/PQ, RTM, and validation reports Experience with GxP systems such as SAP/ERP, MES, LIMS, QMS, DMS, SCADA, BMS, EMS, and data historians Strong understanding of data integrity, audit trails, access controls, backup/recovery, electronic records, and system security Experience with change control, deviations, CAPA, periodic reviews, incident management, and system decommissioning Audit and regulatory inspection support experience Experience with supplier/vendor qualification and cloud technology compliance Strong documentation, communication, risk assessment, and stakeholder-management skills Preferred Certifications GAMP 5 / CSV certification ASQ Certified Quality Auditor ITIL Foundation

ISO 27001 / CISA / CISSP

Project Management or Agile certification #J-18808-Ljbffr United Consulting Hub, Inc.