{"id":2986836,"url":"https://alion.io/job/sanofi-qa-release","title":"QA Release","company":{"id":146,"name":"Sanofi","domain":"sanofi.com","url":"https://alion.io/company/sanofi","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":98,"open_postings":58,"ghost_share":0,"stale_share":0.241,"repost_share":0.069,"time_to_fill_p50_days":21,"computed_at":"2026-10-22T06:10:10Z"}},"role":"QA","role_family":"QA","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Swiftwater, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":69000,"max":99666,"currency":"USD","period":"year","gross":null,"usd_annual":99666},"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Excel","optional":false}],"status":"live","first_seen_at":"2026-10-20T00:00:00Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-22T19:17:45Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Job Title QA Release\nLocation: Swiftwater, PA\nAbout the Job\nYour job, as QA Batch review specialist within our Quality Assurance team, will be to ensure product quality through batch release processes to market for the Swiftwater Site.\nThis role will operate under flexibility to perform the necessary activities to ensure compliance requirements and manufacturing/ release schedules are met. This role supports core activities: Preparation & Certification of Working Documents, Quality Review of Batch Records from Swiftwater and CMOs, Batch Disposition from Swiftwater and CMOs, Quality Review of Lot Release Protocols, Compliance and Performance.\nBenefits of working in this role:\nBe part of an inspiring mission to create life-saving vaccines \nLeading a skilled and motivated team of quality professionals \nThe work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus. \nJoin a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.\nAbout Sanofi:\nWe’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.\nMain Responsibilities\nQuality Review of Batch Records\nPerform final Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, FDA’s 21 CFR, and other applicable health authority regulations. \nComplete all required system transactions associated with the batch record review process. \nProvide data for PDR manufacturing dates and Commodity Verification Sheets to allow further processing of material. \nDisposition of Batches\nReview Specification Checklist, Certificate of Analysis (and Conformance) to verify all required testing has been performed and all testing meets requirements prior to batch disposition. \nVerify CBER release is received (if applicable) prior to batch disposition. \nVerify the lot is not on hold (i.e., deviations, change controls, Approve for Further Manufacture database, etc.) prior to batch disposition. \nVerify all previous manufacturing steps, including raw materials, are satisfactory prior to final disposition of the batch. \nComplete all required system transactions associated with the batch disposition process. \nAct as delegate to the QA Release Lead to provide approval to ship to external manufacturers, as assigned \nQuality Preparation and Review of Lot Release Protocol (LRP)\nPrepare and Review working LRP for completeness and accuracy prior to submission to the applicable Health Authority. \nFor licensed international products- ensure the batch is in full compliance with the GMP requirements and the specifications in the Marketing Authorization of the importing country. \nEnsure LRP review meets cycle time requirements for product releases and SAP confirmation for completion of activity. \nPreparation of Environmental Monitoring Summary (ESUM)\nOversee the ESUM process to ensure timelines and compliance standards are met. \nTake assigned lots and complete ESUM reports by compiling and reviewing data in compliance with area EM procedures, finalizing ESUMS in the electronic ESUM database, and meeting release timelines. \nServe as the SME and function as a liaison for any assigned focus factory initiatives and participate on teams, communicating issues and identifying solutions to support release timelines. \nContribute to team objectives and priorities on assigned projects. \nPreparation & Certification of Working Documents\nPrepare batch records from master documents in the electronic document management system according to procedure \nEnsure right first time preparation and completion of required documentation via electronic system (SAP and/or FaCT) \nProvide support as required to ensure records are prepared and certified in accordance to the production planning schedule. \nCertified prepared batch records to ensure completeness and accuracy in accordance to procedure. \nProvide metrics in support of +QDCI board meetings. \nCompliance and Performance\nMeet department safety, quality, productivity, and cost targets and goals in a compliant and timely manner Act as Trainer for Batch Release activities. \nInvestigate deviations, as assigned. \nPerform special projects as assigned by FFIP QA Leadership team. \nContinuously reviews PQBR processes, and recommends, develops and implements efficiency and quality enhancements. \nPerform CAPA review and approval as required \nCompletion of additional tasks as assigned by team Lead\nKey Involvement in Decision Making:\nPrioritize quality and compliance objectives (D) \nApprove a batch record if it is correctly completed and meets the quality requirement for one lot (D) \nCheck whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D) \nReview documentation for batch disposition (A) \nAdvise on initiatives to promote a quality-focused culture (A) \nAdvise on how to present a topic and answer specific questions (A) \nAbout You\nBasic Qualifications\nBachelor's degree. \n1+ years of experience in a GMP-controlled pharmaceutical environment (e.g., Quality Assurance, Production, Quality Control or related areas).\nTechnical Skills\nAbility to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards.\nCapability to investigate and resolve issues or deviations related to batch release processes efficiently.\nAbility to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards.\nStrong Computer Literacy (including Microsoft excel, power point, word) \nSoft Skills:\nAbility to analyze complex data and identify trends, issues, and solutions \nHigh level of accuracy and attention to detail in all quality assurance activities \nProficiency in identifying problems and implementing effective corrective actions \nStrong verbal and written communication skills for effective interaction with team members and regulatory bodies \nHigh level of autonomy \nWhy choose us?\n Bring the miracles of science to life alongside a supportive, future-focused team. \nDiscover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. \nEnjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. \nTake good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.\nShape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.\nPower industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale\nTransform lives worldwide by delivering life-changing treatments anywhere, anytime.\nSanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.\n#GD-SP \n#LI-SP\n#VHD\nPursue progress, discover extraordinary\nBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.\nSanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here\nUS and Puerto Rico Residents Only\nSanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.\nNorth America Applicants Only\nThe salary range for this position is:\n$69.000,00 - $99.666,66All compensation will be determined commensurate with demonstrated experience. 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