Please post this requirement. Title Sr. Software Quality Assurance Analyst (Life Sciences Computer Systems Validation projects) W-2 Only Minimum 8+ years of experience No H1-B, No OPT Location OH (Onsite) Note: Looking for a candidate who can explain SQA duties and related work experience in detail. This role is with our Client. Rate Negotiable based on the experience (discuss with our recruiter) Job Description: Company Overview: OneUS Technologies, a leading staffing player in the life sciences industry, is seeking a highly motivated and detail-oriented Software Quality Assurance Analyst to join our Client s project team. This is a contract role for our client. Job Summary: As a Software Quality Assurance Analyst specialized in Computer Systems Validation for the life sciences industry, you will play a critical role in ensuring the integrity, functionality, and regulatory compliance of computer systems used in various life sciences processes. You will collaborate closely with multidisciplinary teams, combining your knowledge of quality assurance with regulatory expertise to guarantee the validity of software systems and adherence to industry standards. Key Responsibilities: CSV Planning: Review comprehensive Computer Systems Validation plans for software applications used in life sciences processes. Ensure that validation processes align with industry regulations, including GxP, 21 CFR Part 11, and other relevant standards. Validation Protocols: Review and approve validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as well as User Acceptance Testing (UAT) for software applications. Risk Assessment: Conduct risk assessments to identify potential issues, prioritize validation activities, and determine the scope of testing required. Documentation: Maintain meticulous records of all validation activities, including test cases, test results, and validation documentation. Prepare validation reports that summarize findings and demonstrate compliance. Test Execution: Review executed validation tests, both manual and automated, ensuring that software systems perform as intended and meet regulatory requirements. Regulatory Compliance: Stay current with regulatory guidelines and industry standards related to computer systems validation, and ensure that all systems are in compliance. Change Control: Assess and validate changes to software systems, ensuring that modifications do not impact system functionality, data integrity, or regulatory compliance. Defect Management: Identify, document, track, and guide project teams on reporting defects during validation activities, and work closely with development teams to resolve issues. Validation Tools: Utilize specialized validation tools and software to support validation processes. Collaboration: Collaborate with cross-functional teams, including software developers, project managers, validation teams, and regulatory experts to ensure a cohesive approach to computer systems validation. Qualifications: Bachelor's degree in Computer Science, Life Sciences, or a related field. Proven experience in computer systems validation as an SQA within the life sciences industry. Strong knowledge of regulatory requirements and industry standards, including GxP, 21 CFR Part 11, and Annex 11, Risk based approach GAMP5, FMEA, Data Integrity ALCOA. Proficiency in reviewing and approving validation protocols and test cases (Quality Oversight) Experience with test automation tools and risk assessment methodologies. Strong analytical and problem-solving skills. Detail-oriented with a commitment to delivering high-quality work. Excellent communication and teamwork skills. Familiarity with FDA regulations and guidelines related to computer systems validation is a plus.