{"id":131054,"date":"2026-08-14T18:58:51","date_gmt":"2026-08-14T18:58:51","guid":{"rendered":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1470389aj_1786733931-senior-quality-assurance-scientist-storrs-connecticut\/"},"modified":"2026-08-14T21:16:28","modified_gmt":"2026-08-14T21:16:28","slug":"lsnjn1470389aj_1786733931-senior-quality-assurance-scientist-storrs-connecticut","status":"publish","type":"job_listing","link":"https:\/\/bhsg.com\/jobs\/job\/lsnjn1470389aj_1786733931-senior-quality-assurance-scientist-storrs-connecticut\/","title":{"rendered":"Senior Quality Assurance Scientist"},"content":{"rendered":"<h4><strong><a id=\"myCustomID\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/LSNJN1470389AJ_1786733931\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n<div style=\"direction: ltr; border-width: 100%;\">\n<div style=\"direction: ltr; margin-top: 0in; margin-left: 0in; width: 7.6041in;\">\n<div style=\"direction: ltr; margin-top: 0in; margin-left: 0in; width: 7.6041in;\">\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\"><span style=\"font-weight: bold;\">Position Summary<\/span><\/p>\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\">\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\">We are seeking a highly skilled and experienced <span style=\"font-weight: bold;\">Senior Quality Assurance (QA) Scientist<\/span> to join our client&#8217;s team. In this senior-level role, you will be a key driver of product quality, regulatory compliance, and continuous improvement initiatives across the organization. You will apply deep technical expertise to design and execute quality systems and serve as a cross-functional quality partner to R&amp;D, manufacturing, and regulatory affairs.<\/p>\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\">\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\"><span style=\"font-weight: bold;\">Key Responsibilities<\/span><\/p>\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\">\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\"><span style=\"font-weight: bold;\">Quality Systems &amp; Compliance<\/span><\/p>\n<ul style=\"direction: ltr; unicode-bidi: embed; margin-top: 0in; margin-bottom: 0in;\" type=\"disc\">\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Design, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with applicable regulatory standards (ISO 9001, ISO 13485, 21 CFR Part 820, or industry equivalent).<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Lead and manage internal and external audits, including pre-audit preparation, execution, and CAPA follow-up.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Maintain current knowledge of applicable regulations (FDA, EU MDR, ICH, GxP) and ensure organizational compliance through proactive gap assessments.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Develop, review, and approve SOPs, work instructions, and quality documentation to ensure clarity and regulatory adherence.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Oversee change control processes, ensuring all changes are properly documented, evaluated for risk, and validated prior to implementation.<\/span><\/li>\n<\/ul>\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\"><span style=\"font-weight: bold;\">Testing, Validation &amp; Analytical Methods<\/span><\/p>\n<ul style=\"direction: ltr; unicode-bidi: embed; margin-top: 0in; margin-bottom: 0in;\" type=\"disc\">\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Design and execute validation protocols (IQ\/OQ\/PQ) for equipment, processes, software, and analytical methods.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Develop and validate test methods in compliance with relevant pharmacopeial or industry standards; perform method transfers.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Lead root cause investigation and failure analysis using structured problem-solving methodologies (8D, Ishikawa, 5-Why, FMEA).<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Review and approve batch records, test results, and deviations; ensure disposition decisions are science-based and defensible.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Oversee stability programs, environmental monitoring, and in-process controls to ensure product integrity.<\/span><\/li>\n<\/ul>\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\"><span style=\"font-weight: bold;\">Cross-Functional Leadership &amp; Continuous Improvement<\/span><\/p>\n<ul style=\"direction: ltr; unicode-bidi: embed; margin-top: 0in; margin-bottom: 0in;\" type=\"disc\">\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Serve as the quality representative on cross-functional project teams, providing QA guidance from design through launch.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Partner with R&amp;D, Regulatory Affairs, Manufacturing, and Supply Chain to drive quality-by-design principles.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Lead Corrective and Preventive Action (CAPA) system; track and report trends in quality metrics to senior leadership.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Mentor and coach junior QA staff, fostering a culture of quality, accountability, and continuous improvement.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Identify and implement process improvement initiatives using Lean, Six Sigma, or other quality improvement frameworks.<\/span><\/li>\n<\/ul>\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\">\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\"><span style=\"font-weight: bold;\">Qualifications<\/span><\/p>\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\">\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\"><span style=\"font-weight: bold;\">Required<\/span><\/p>\n<ul style=\"direction: ltr; unicode-bidi: embed; margin-top: 0in; margin-bottom: 0in;\" type=\"disc\">\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Bachelor&#8217;s degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline; Master&#8217;s or Ph.D. preferred.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Minimum 7 years of progressive, hands-on quality assurance experience in a regulated industry (pharmaceutical, biotech, medical device, or equivalent).<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">In-depth knowledge of quality regulations and standards: FDA 21 CFR Parts 210\/211\/820, ISO 13485, ICH Q7\/Q8\/Q9\/Q10, EU GMP Annex, or equivalent.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Proven experience designing and executing validation protocols (process, method, equipment, CSV\/computer systems).<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Demonstrated experience leading or supporting regulatory inspections (FDA, EMA, ISO\/Notified Body) with successful outcomes.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Strong root cause analysis skills with hands-on use of tools such as FMEA, Fishbone, 5-Why, and 8D.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Experience authoring, reviewing, and approving complex quality documentation including SOPs, protocols, and technical reports.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Proficiency with quality management software (e.g., MasterControl, Veeva, TrackWise, or similar platforms).<\/span><\/li>\n<\/ul>\n<p style=\"margin: 0in; font-family: 'Segoe UI'; font-size: 12.0pt;\"><span style=\"font-weight: bold;\">Preferred<\/span><\/p>\n<ul style=\"direction: ltr; unicode-bidi: embed; margin-top: 0in; margin-bottom: 0in;\" type=\"disc\">\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent professional certification.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Six Sigma Green Belt or Black Belt certification.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Experience with electronic batch record systems and data integrity programs (21 CFR Part 11 \/ Annex 11).<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Prior experience with combination products or Class II\/III medical devices.<\/span><\/li>\n<li style=\"margin-top: 0; margin-bottom: 0; vertical-align: middle;\"><span style=\"font-family: 'Segoe UI'; font-size: 12.0pt;\">Familiarity with supplier quality management and qualification programs.<\/span><\/li>\n<\/ul>\n<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p><img decoding=\"async\" src=\"https:\/\/counter.adcourier.com\/bGlmZXNjaWVuY2VzbmpuLjQ5MzQxLjEyNTg0QGJlYWNvbmhpbGwuYXBsaXRyYWsuY29t.gif\"><\/p>\n<p><span style=\"color: #ffffff;\">LSNJN1470389AJ_1786733931<\/span><\/p>\n<h4><strong><a id=\"otherId\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/LSNJN1470389AJ_1786733931\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n","protected":false},"author":0,"featured_media":3770,"template":"","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","inline_featured_image":false,"_promoted":"","_job_location":"Storrs, Connecticut","_application":"lifesciencesnjn.49341.12584@beaconhill.aplitrak.com","_company_name":"Beacon Hill Staffing Group","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-categories":[213,234,556,215],"job-types":[2,16],"class_list":["post-131054","job_listing","type-job_listing","status-publish","has-post-thumbnail","hentry","job-type-full-time","job-type-temporary-contract"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Senior Quality Assurance Scientist Storrs Connecticut<\/title>\n<meta name=\"description\" content=\"Senior Quality Assurance Scientist Storrs Connecticut - Apply with Beacon Hill Staffing Services for this Senior Quality Assurance Scientist job in Storrs, Connecticut\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/bhsg.com\/jobs\/job\/lsnjn1470389aj_1786733931-senior-quality-assurance-scientist-storrs-connecticut\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Senior Quality Assurance Scientist Storrs Connecticut\" \/>\n<meta property=\"og:description\" content=\"Senior Quality Assurance Scientist Storrs Connecticut - Apply with Beacon Hill Staffing Services for this Senior Quality Assurance Scientist job in Storrs, Connecticut\" \/>\n<meta property=\"og:url\" content=\"https:\/\/bhsg.com\/jobs\/job\/lsnjn1470389aj_1786733931-senior-quality-assurance-scientist-storrs-connecticut\/\" \/>\n<meta property=\"og:site_name\" content=\"Nationwide Staffing Agency | Temp &amp; 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