Senior Quality Assurance Specialist

Bachelors degree in information technology or related field; and 6 years of relevant experience 10+ years of experience working in at least one of the following regulatory settings: FDA 21 CFR 11, Annex 11, ISO 27001, SOX, HIPAA, HITECH, CLIA, CAP, GCP. Experience in clinical trials and clinical laboratory, biotech or Pharma industry with focus on computerized systems, IT processes and regulatory compliance. Plan and perform audits of IT and technology vendors, Review audit findings and validation reports to assess compliance gaps and system risks. Actively participate in root cause analysis (RCA) sessionsand collaborate with cross-functional SMEs to agree/approve robust and effective Corrective and Preventive Actions (CAPAs) Assist withrisk assessments of new and proposed technologies including contributions to Artificial Intelligent (AI) advisory team Create, Approve and ensure internal LC SOPs and processes are designed for regulatory compliance as applicable to computerized systems and data integrity, data privacy (e,g GxP, FDA 21 CFR Part 11, and EU Annex 11) Ensure proper documentation for CSV and Data Integrity projects, including risk control metrices, compliance assessments, process narratives, testing, issue evaluation, and reporting. Manage and execute day-to-day compliance operational tasks, including client and vendor IT questionnaires, compliance metrics reporting, audit finding responses, internal audits, and document reviews. Conduct comprehensive IT supplier qualification reviews to assess the compliance, reliability, and data integrity practices of third-party vendors. Ensure life cycle management of GxP Computerized systems through QMS policies, documentation and change control. Prepare KPIs in support of quality reporting to management. Assist in other QA tasks as assigned, including Veeva Vault workflows, reporting and configurations. Identify opportunities for continuous quality improvement by analyzing validation processes, audit findings, and system performance metrics. Develop and implement actionable plans to enhance compliance, efficiency, and data integrity across computerized systems. Keep abreast of regulatory and IT compliance developments and evolving best practices in compliance control and data integrity. Education and Experience: Specific QA roles overseeing computerized systems life cycle and DI policies and procedures. Experience with core IT applications used in a regulated environment, including Veeva, LIMS etc. Skills and Ability: Ability to take the initiative, dependable, and work with little supervision while being resilient to change Ability to work within a fast-paced, cross-cultural, and cross-functional team environment Ability to adhere to established timelines, processes and procedures Excellent attention to detail. Strong planning and problem-solving skills. Self-motivating and ability to work well independently as well as using a collaborative team approach. Ability to adapt to changing environments and requirements. Excellent organization and time management skills, communication, multitasking, interpersonal and listening skills. Ability to adhere to quality and regulatory requirements while still meeting business needs. Cloud Hybrid is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. Cloud Hybrid will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will Cloud Hybrid require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract #J-18808-Ljbffr