We are looking for an innovative and experienced Quality Analyst to join our team. The QA Analyst is responsible for developing all testing-related documents and executing test scripts for assigned projects using recommended quality guidelines. The role also provides additional support to Deployment Solutions' QMS as requested. Job Responsibilities Computer System Validations Plan and execute system validations of client configurations and / or vendor software services with regulatory implications (PDMA, 21 CFR Part 11). Prepare and deliver Validation Plans, Protocols (OQ, PQ), and Traceability Matrices. Execute protocols and document testing evidence. Prepare and deliver Validation Summary Reports. CRM QA Testing Prepare and deliver Test Plans covering all requirements. Write / modify test scripts and scenarios. Prepare and deliver test datasets to represent Rep activities and functional triggers. Coordinate required data files for testing with third parties via Data Services. Execute test scripts and assist with execution and documentation. Document deviations and prepare Test Summary Reports. Deployment Solutions QMS Support Assist in documentation management, including SOPs, Work Instructions, Policies, Standards, validation packages, and testing scripts / evidence. Support additional QMS activities as scope increases. Qualification Requirements Required BA / BS in Computer Science or equivalent. 3+ years of computer system validations in a regulated industry. 3+ years supporting the pharmaceutical and / or medical device industry. 3+ years performing validation / testing to PDMA and 21 CFR Part 11. Preferred SFA / CRM background. Experience with Salesforce or Veeva CRM. Testing across multiple platforms. Quality Management background. Skills Adherence to current Good Documentation Practices (cGDP). Strong multi-tasking, time management, and organizational skills. Analytical and detail-oriented. Strong interpersonal skills and ability to work under pressure. Proficient in Microsoft Office (Word, Excel). Troubleshooting and problem-solving skills. Ability to translate business needs into technical requirements. At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities. Why Syneos Health? We partner with industry experts to solve and execute against today's toughest commercialization challenges facing the world's leading healthcare companies. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities on our Commercial Operations and Leadership teams. Join our game-changing, general company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world. W o r k H e r e M a t t e r s E v e r y w h e r e | How are you inspired to change lives? Syneos Health companies are affirmative action / equal opportunity employers (Minorities / Females / Veterans / Disabled) Discover what our more than 29,000 employees already know : work here matterseverywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday workimprovespatients' lives around the world. Selecting us as an employer secures acareer inwhich you're guaranteed to : Syneos Health is a leading fully integrated biopharmaceutical solutions organization builtto accelerate customer success. We translate unique clinical, medical affairs and commercialinsights into outcomes to address modern market realities. To learn more about how we areShortening the distance from lab to life, visit syneoshealth.com . Syneos Health is an Equal Opportunity Employer. All qualified applicants will receiveconsideration for employment without regard to race, color, age, religion, marital status,ethnicity, national origin, sex, gender, gender identity, sexual orientation, protectedveteran status, disability or any other legally protected status and will not bediscriminated against. If you are an individual with a disability who requires reasonableaccommodation to complete any part of our application process, including the use of thiswebsite, please contact us at : Email : (emailprotected) One of our staff members willwork with you to provide alternate means to submit your application. #J-
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