{"schemaVersion":"jobsearcher.job.v1","id":"99fc184aba44911dfc5378e3","url":"https://jobsearcher.com/jobs/99fc184aba44911dfc5378e3","canonicalUrl":"https://jobsearcher.com/jobs/99fc184aba44911dfc5378e3","title":"Sr QA Scientist","description":"*Job Summary*\n\n* Advanced experience in Quality Systems, with demonstrated expertise in Change Control, Validation, Equipment and Facilities Lifecycle Management, Process Qualification (PQ), Process Performance Qualification (PPQ), and associated Quality documentation within a regulated GxP environment.\n* *Strong independent decision-making skills with the ability to influence others and drive alignment across teams. *\n* Proven experience supporting regulatory inspections and audits, including demonstrated ability to interact with regulatory agencies and contribute to successful inspection outcomes.\n* *Proven ability to evaluate quality and compliance risks through risk-based decision making and drive cross-functional alignment to achieve compliant outcomes.*\n* Experience supporting drug product operations in a GMP-regulated environment. *Proficient technical writing skills with the ability to produce concise, objective, evidence-based, inspection-ready documentation in compliance with ALCOA+ and Good Documentation Practices. *\n* Strong sense of accountability and ownership, with the ability to manage multiple high-impact Quality System deliverables simultaneously and deliver timely, compliant outcomes.\n* *Demonstrated ability to evaluate compliance issues, perform advanced data trending and analysis, and assess systemic quality risks. * Ability to identify systemic quality signals, recurring process issues, and cross-functional process vulnerabilities through trend analysis, lifecycle monitoring, and prior event assessment.\n* *Experience supporting Change Controls, Validation activities, Equipment and Facilities Lifecycle Management, Process Qualification (PQ), Process Performance Qualification (PPQ), Periodic Monitoring, Process Reviews, and Annual Product Reviews (APR). *\n* Technically savvy and adaptable, with openness to leveraging digital tools, automation, and emerging technologies (including AI-enabled tools) to improve Quality System effectiveness.\n* Bachelors Degree in LifeSciences, must have excellent communication (read, write & Speak) in English & Spanish.\n\nPay: $35.00 - $48.00 per hour\n\nWork Location: In person","company":"Ispv","rawCompany":"ispv","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-09-04T11:10:23.805Z","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":"13-1041.07","title":"Regulatory Affairs Specialists","slug":"regulatory-affairs-specialists"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"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"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr QA Scientist","description":"*Job Summary*\n\n* Advanced experience in Quality Systems, with demonstrated expertise in Change Control, Validation, Equipment and Facilities Lifecycle Management, Process Qualification (PQ), Process Performance Qualification (PPQ), and associated Quality documentation within a regulated GxP environment.\n* *Strong independent decision-making skills with the ability to influence others and drive alignment across teams. *\n* Proven experience supporting regulatory inspections and audits, including demonstrated ability to interact with regulatory agencies and contribute to successful inspection outcomes.\n* *Proven ability to evaluate quality and compliance risks through risk-based decision making and drive cross-functional alignment to achieve compliant outcomes.*\n* Experience supporting drug product operations in a GMP-regulated environment. *Proficient technical writing skills with the ability to produce concise, objective, evidence-based, inspection-ready documentation in compliance with ALCOA+ and Good Documentation Practices. *\n* Strong sense of accountability and ownership, with the ability to manage multiple high-impact Quality System deliverables simultaneously and deliver timely, compliant outcomes.\n* *Demonstrated ability to evaluate compliance issues, perform advanced data trending and analysis, and assess systemic quality risks. * Ability to identify systemic quality signals, recurring process issues, and cross-functional process vulnerabilities through trend analysis, lifecycle monitoring, and prior event assessment.\n* *Experience supporting Change Controls, Validation activities, Equipment and Facilities Lifecycle Management, Process Qualification (PQ), Process Performance Qualification (PPQ), Periodic Monitoring, Process Reviews, and Annual Product Reviews (APR). *\n* Technically savvy and adaptable, with openness to leveraging digital tools, automation, and emerging technologies (including AI-enabled tools) to improve Quality System effectiveness.\n* Bachelors Degree in LifeSciences, must have excellent communication (read, write & Speak) in English & Spanish.\n\nPay: $35.00 - $48.00 per hour\n\nWork Location: In person","datePosted":"2026-09-04T11:10:23.805Z","dateModified":"2026-09-04T11:10:23.805Z","hiringOrganization":{"@type":"Organization","name":"Ispv","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"99fc184aba44911dfc5378e3"},"url":"https://jobsearcher.com/jobs/99fc184aba44911dfc5378e3"}}