QC Analyst

Job title: QC AnalystLocation: Swiftwater, PAAbout the jobJoin 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. About SanofiWe’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 people’s lives. Main responsibilities:Test Data Review:Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualifiedPerforming the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plansInforming his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriatelySupport root cause analysis investigations for testing deviationsDocument coordination:Coordinate quality control documentation lifecycle activitiesManage document workflows, including review, approval, and distribution processesEnsure documentation compliance with good documentation practices (GDP)Create, maintain, and update QC technical documentation and SOPsMonitor document revision schedules and coordinate periodic reviewsLiaise with subject matter experts (SMEs) for document content developmentSupport metadata management and document control activities in quality systems (e.g., QualiPSO)Coordinate stakeholder reviews and consolidate feedbackOther accountabilities:Executing assigned CAPAs related to remediation plans, continuous improvementsEnsuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately.Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plansPerforming his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasksRecording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirementsSupporting laboratory and deviation investigationsTypical Activities:Review test data for accuracy, completeness, and complianceCoordinate the creation, review, and approval of QC SOPs and technical documentsManage document change requests and assess impact on testing operationsFacilitate document review meetings with cross-functional teamsMaintain document control records and ensure proper version managementSupport regulatory inspections by providing documentation and technical expertiseParticipate in CAPA investigations related to testing or documentation issuesMonitor documentation metrics and report on completion statusTrain laboratory personnel on new or revised proceduresAbout youKey Qualifications:Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field3-5 years of experience in QC laboratory operations. Working in a pharmaceutical environment is preferred.Strong understanding of GxP requirements and/or pharmaceutical quality systemsExperience with analytical testing methods and equipmentProficiency in document management systems (e.g., QualiPSO, electronic document management systems)Knowledge of test data review processes and data integrity principlesExperience coordinating documentation workflows and managing stakeholder reviewsExcellent attention to detail and organizational skillsStrong written and verbal communication skillsKnowledge of iShift functionality and navigation is preferredWhy Choose Us?Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take 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. Sanofi US Services 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. #GD-SP ​ #LI-SP #LI-Onsite#vhdPursue progress, discover extraordinaryBetter 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.Sanofi 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 View phone number on job-api.jobget.com) or click hereUS and Puerto Rico Residents OnlySanofi 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.North America Applicants OnlyThe salary range for this position is:$27.24 - $36.32All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.SummaryLocation: Swiftwater, PAType: Full time