{"schemaVersion":"jobsearcher.job.v1","id":"22b0cdbad88240345ee6d71a","url":"https://jobsearcher.com/jobs/22b0cdbad88240345ee6d71a","canonicalUrl":"https://jobsearcher.com/jobs/22b0cdbad88240345ee6d71a","title":"Expert - QA Technical Operations","description":"About GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.The Expert of QA Technical Operations will be responsible for:Interpreting, building upon, and complying with company quality assurance standardsManaging daily supplier quality activities and controlsSupporting the Strategic Supplier Management process to meet quality, delivery, and cost objectivesDeveloping and executing strategic plans to improve supplier quality, delivery, and costsOverseeing inbound material release processChampion quality assurance procedures, tools, and techniquesRoles and ResponsibilitiesAuthor/Review SOPsOversee the GMP supplier qualification program and supplier risk managementCompletes the approval requirements to qualify new suppliers including negotiating quality agreements, as well as audit scheduling, conduction of audits, and authoring of audit reportsPeriodic review of suppliers and identification of supplier compliance issuesManages vendor complaintsParticipates in or manages quality assessments of internal operations and suppliers to analyze compliance and assess riskLiaison between Supplier and QA representatives in addressing the quality concerns from the supply chainMonitor supplier non-conformance performance, and drive root-cause analyses, corrective actions & process improvements to reduce the Number of Defects & Cost of QualityEnsures effective and timely investigation and closure of all CAPAs, supplier non conformances, complaints, and product issuesDevelopment and maintenance of measurement systems for quality costs, indicators, trends and supplier ratingCollects data and compiling supplier scorecardsManages audit schedule and executes supplier auditsGenerates specifications for materials and consumablesResponsible for disposition of materials and consumablesApprove calibration reports for GMP equipmentSupport QA Validation in review of SOPsMay interface with auditors during regulatory inspectionsWorks closely with Facilities, QA Validation, Manufacturing, and QC teamsTravel expectations:Bachelor's degree in science, Engineering, Business, Management or related field (Advance degree a plus)3-5+ years of experience in Quality, Manufacturing, Engineering, or related fieldResults oriented, driven individualExcellent interpersonal, communication and negotiation skillsStrong organizational and problem-solving abilitiesHigh attention to detail and accuracyAbility to work collaboratively in a team environmentThe estimated pay range for the role is between $70,000 - $95,000 based on qualifications and experience.#LW#PBGenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.","company":"Genscriptprobio","rawCompany":"genscriptprobio","city":"Pennington","state":"NJ","isRemote":false,"isActive":false,"createdAt":"2026-05-03T09:05:59.353Z","occupations":[{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4013.00","title":"Food Science Technicians","slug":"food-science-technicians"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Expert - QA Technical Operations","description":"About GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.The Expert of QA Technical Operations will be responsible for:Interpreting, building upon, and complying with company quality assurance standardsManaging daily supplier quality activities and controlsSupporting the Strategic Supplier Management process to meet quality, delivery, and cost objectivesDeveloping and executing strategic plans to improve supplier quality, delivery, and costsOverseeing inbound material release processChampion quality assurance procedures, tools, and techniquesRoles and ResponsibilitiesAuthor/Review SOPsOversee the GMP supplier qualification program and supplier risk managementCompletes the approval requirements to qualify new suppliers including negotiating quality agreements, as well as audit scheduling, conduction of audits, and authoring of audit reportsPeriodic review of suppliers and identification of supplier compliance issuesManages vendor complaintsParticipates in or manages quality assessments of internal operations and suppliers to analyze compliance and assess riskLiaison between Supplier and QA representatives in addressing the quality concerns from the supply chainMonitor supplier non-conformance performance, and drive root-cause analyses, corrective actions & process improvements to reduce the Number of Defects & Cost of QualityEnsures effective and timely investigation and closure of all CAPAs, supplier non conformances, complaints, and product issuesDevelopment and maintenance of measurement systems for quality costs, indicators, trends and supplier ratingCollects data and compiling supplier scorecardsManages audit schedule and executes supplier auditsGenerates specifications for materials and consumablesResponsible for disposition of materials and consumablesApprove calibration reports for GMP equipmentSupport QA Validation in review of SOPsMay interface with auditors during regulatory inspectionsWorks closely with Facilities, QA Validation, Manufacturing, and QC teamsTravel expectations:Bachelor's degree in science, Engineering, Business, Management or related field (Advance degree a plus)3-5+ years of experience in Quality, Manufacturing, Engineering, or related fieldResults oriented, driven individualExcellent interpersonal, communication and negotiation skillsStrong organizational and problem-solving abilitiesHigh attention to detail and accuracyAbility to work collaboratively in a team environmentThe estimated pay range for the role is between $70,000 - $95,000 based on qualifications and experience.#LW#PBGenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.","datePosted":"2026-05-03T09:05:59.353Z","dateModified":"2026-05-03T09:05:59.353Z","hiringOrganization":{"@type":"Organization","name":"Genscriptprobio","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Pennington","addressRegion":"NJ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"22b0cdbad88240345ee6d71a"},"url":"https://jobsearcher.com/jobs/22b0cdbad88240345ee6d71a"}}