{"schemaVersion":"jobsearcher.job.v1","id":"fc7b3b3fa4c84ef482fdd8e3","url":"https://jobsearcher.com/jobs/fc7b3b3fa4c84ef482fdd8e3","canonicalUrl":"https://jobsearcher.com/jobs/fc7b3b3fa4c84ef482fdd8e3","title":"Quality Engineer (Pharmaceutical)","description":"Quality Engineer (Pharmaceutical)\nQuality Assurance\n\nIrvine , California, US\n\nAdded - 26/05/2026\n\nPay Rate Low: 100000 | Pay Rate High: 120000\n\nOpportunity to join a rapidly growing pharmaceutical organization in a highly impactful Quality Engineer capacity.\n\nSalary: $100-120k/yr\n\nHybrid (Irvine OR LA)\n\nPosition Overview\nWe are looking for a Quality Engineer to support quality assurance, process optimization, and regulatory compliance within a regulated manufacturing environment. This role works closely with cross-functional teams to identify quality concerns, improve operational processes, and ensure products consistently meet safety and compliance standards.\n\nPrimary Responsibilities\n\nLead investigations into manufacturing deviations and quality issues, including root cause analysis and corrective/preventive actions (CAPA).\n\nMonitor and improve quality performance metrics to support continuous improvement initiatives.\n\nCreate, revise, and maintain SOPs to enhance efficiency and regulatory compliance.\n\nPerform risk assessments (FMEA) and assist with implementation of quality-related projects.\n\nManage product specifications, supplier qualification activities, and third-party audits.\n\nCoordinate external product certifications such as Halal, Kosher, and NSF.\n\nSupport recall readiness, mock recalls, and post-market quality monitoring activities.\n\nReview new products and formulations to ensure compliance with quality and regulatory standards.\n\nRequired Qualifications\n\nBachelor’s degree in Biology, Chemical Engineering, or a related scientific discipline.\n\nMinimum of 3 years of experience in quality assurance within regulated industries such as pharmaceuticals, medical devices, food, cosmetics, or dietary supplements.\n\nHands‑on experience with validation processes, risk management, and quality systems.\n\nStrong understanding of cGMP regulations, FDA requirements (21 CFR 111, 117, 210, 211), and ISO 22716 standards.\n\nKnowledge of Six Sigma principles and statistical analysis tools.\n\nWillingness to travel domestically and internationally when required.\n\nWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.\n\n#J-18808-Ljbffr","company":"Astrix Technology","rawCompany":"astrix technology","city":"Irvine","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-06-20T04:15:35.343Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer (Pharmaceutical)","description":"Quality Engineer (Pharmaceutical)\nQuality Assurance\n\nIrvine , California, US\n\nAdded - 26/05/2026\n\nPay Rate Low: 100000 | Pay Rate High: 120000\n\nOpportunity to join a rapidly growing pharmaceutical organization in a highly impactful Quality Engineer capacity.\n\nSalary: $100-120k/yr\n\nHybrid (Irvine OR LA)\n\nPosition Overview\nWe are looking for a Quality Engineer to support quality assurance, process optimization, and regulatory compliance within a regulated manufacturing environment. This role works closely with cross-functional teams to identify quality concerns, improve operational processes, and ensure products consistently meet safety and compliance standards.\n\nPrimary Responsibilities\n\nLead investigations into manufacturing deviations and quality issues, including root cause analysis and corrective/preventive actions (CAPA).\n\nMonitor and improve quality performance metrics to support continuous improvement initiatives.\n\nCreate, revise, and maintain SOPs to enhance efficiency and regulatory compliance.\n\nPerform risk assessments (FMEA) and assist with implementation of quality-related projects.\n\nManage product specifications, supplier qualification activities, and third-party audits.\n\nCoordinate external product certifications such as Halal, Kosher, and NSF.\n\nSupport recall readiness, mock recalls, and post-market quality monitoring activities.\n\nReview new products and formulations to ensure compliance with quality and regulatory standards.\n\nRequired Qualifications\n\nBachelor’s degree in Biology, Chemical Engineering, or a related scientific discipline.\n\nMinimum of 3 years of experience in quality assurance within regulated industries such as pharmaceuticals, medical devices, food, cosmetics, or dietary supplements.\n\nHands‑on experience with validation processes, risk management, and quality systems.\n\nStrong understanding of cGMP regulations, FDA requirements (21 CFR 111, 117, 210, 211), and ISO 22716 standards.\n\nKnowledge of Six Sigma principles and statistical analysis tools.\n\nWillingness to travel domestically and internationally when required.\n\nWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.\n\n#J-18808-Ljbffr","datePosted":"2026-06-20T04:15:35.343Z","dateModified":"2026-06-20T04:15:35.343Z","hiringOrganization":{"@type":"Organization","name":"Astrix Technology","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Irvine","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"fc7b3b3fa4c84ef482fdd8e3"},"url":"https://jobsearcher.com/jobs/fc7b3b3fa4c84ef482fdd8e3"}}