25 quality systems specialist jobs at 21 companies in Marshfield, MA
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Principal Quality Systems Specialist
Northridge or California or Seattle or Washington or Boston or New York City or Los Angeles County or United States
$121k-$205k/yr OnsiteFull Time
5+ YOEBaccalaureate degree with 7+ years (or advanced degree with 5+ years) in quality systems; experience with QMS, Change Management, CAPA, audits, and Microsoft Office; strong communication and prioritization skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Agile, Trackwise, Microsoft Teams, Microsoft Project, Power BI
1w
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Senior Quality Systems Specialist
Cambridge, Massachusetts, United States
$107k-$139k/yr OnsiteFull Time
5+ YOEBachelor’s degree in life sciences or biopharma with 5+ years of quality systems experience, or 7+ years relevant GLP/GMP experience without a degree; QMS, CAPA, audit, regulatory, analytical, and communication skills required.
Electronic Laboratory Notebook, Quality Management Systems (QMS), CAPA, Microsoft?, Qualio, Veeva, Benchling
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Senior Quality Systems Specialist
Boston, Massachusetts, United States
$95k-$105k/yr OnsiteFull Time
5+ YOE5+ years in quality assurance/systems in regulated manufacturing; experience with CAPA, deviations, investigations, change and document control, audits, SOPs, root cause analysis, QMS/ERP, and strong written documentation and cross-functional collaboration.
QMS, ERP
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Lead Quality Systems Specialist
Lawrence, Massachusetts, United States
$117k-$196k/yr OnsiteFull Time
6+ YOEBachelor's degree, 6+ years related experience, deep knowledge of quality systems, recalls/corrections & removals, regulatory requirements (US, Health Canada, Mexico), Microsoft Access/Outlook/ERP skills, audit and training experience.
Microsoft Access, Microsoft Outlook, ERP software, Microsoft Office
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Senior Specialist or Manager, Quality Systems
Watertown, Massachusetts, United States
$85k-$200k/yr OnsiteFull Time
5+ YOEBachelor's in life sciences, 5+ years quality systems/GxP/document control experience in a sponsor organization, hands-on eQMS administration, GxP training program management, knowledge of 21 CFR Part 11 and ICH E6(R3).
Veeva Vault, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
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Quality Systems Specialist I, Digital Health
Boston, Massachusetts, United States
$105k-$135k/yr OnsiteFull Time
2+ YOEBachelor's in engineering or life sciences,2+ years QMS/QA experience in medical device or digital health,working knowledge of ISO 13485 and 21 CFR Part 820,QMS processes (CAPA,complaints,audits),and eQMS experience.
eQMS
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North America Service Quality Specialist
Burlington, Massachusetts, United States
$84k-$127k/yr OnsiteFull Time
2+ YOEBachelor's degree and 2+ years of quality management systems experience plus 1+ year of QA experience. Knowledge of ISO 9001, auditing, communication, organization, and time management preferred.
ISO 9001, Quality Management System (QMS)
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North America Service Quality Specialist
Burlington, Massachusetts, United States
$84k-$127k/yr OnsiteFull Time
2+ YOEBachelor's degree, 2+ years of Quality Management Systems experience, and 1+ year of QA experience. ISO 9001, auditing, cGMP, communication, organization, and team-building skills preferred.
Quality Management System (QMS), ISO 9001, LS Audit Standard (040091MP), cGMP, Key Quality Indicators (KQIs)
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North America Service Quality Specialist
Burlington, Massachusetts, United States
$84k-$127k/yr OnsiteFull Time
2+ YOEBachelor's degree, 2+ years of Quality Management Systems experience, 1+ year of QA experience, and knowledge of ISO 9001-based systems. Pharmaceutical and auditing experience preferred.
Quality Management System (QMS), ISO 9001, Key Quality Indicators (KQIs), Integrated Management Reviews
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Quality Assurance Specialist
Mansfield, Massachusetts, United States
$60k-$68k/yr OnsiteFull Time
High school diploma/GED, exceptional attention to detail, process-oriented, proficiency in Microsoft Word and Excel, familiarity with ASME and Oracle systems preferred, legal US work authorization required.
Microsoft Word, Microsoft Excel, Oracle
4w
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Principal Clinical Quality Assurance Specialist
Maple Grove or Arden Hills or Marlborough
$117k-$222k/yr HybridFull Time
5+ YOEBachelor's degree, 5+ years clinical QA experience including GCP audits, working knowledge of ISO 14155/13485/GCP/GMP/GDP, CAPA and quality systems experience, ability to travel up to 30%.
ISO 14155, ISO 13485, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP)
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Quality Assurance Specialist
Boston, Massachusetts, United States
$99k-$109k/yr OnsiteFull Time
Experience in cell processing quality systems, auditing, regulatory compliance (FACT, FDA, JCAHO, AABB, CLIA), proficiency with databases and spreadsheets, strong analytical and communication skills.
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Senior Quality Training Specialist
Waltham, Massachusetts, United States
$119k-$145k/yr HybridFull Time
8+ YOEBachelor's degree and 8+ years in pharmaceutical or biotechnology Quality, Quality Systems, training, or related work. Requires GxP, QMS, LMS, adult-learning, facilitation, compliance, and analytical skills.
Quality Management System (QMS), Learning Management System (LMS), GxP
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Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens - MA
Devens, Massachusetts, United States
$90k-$109k/yr OnsiteFull Time
4+ YOEBachelor's degree in STEM preferred; high school diploma or associate degree may qualify with equivalent experience. Requires 4+ years in a regulated industry, including 1+ year in deviation investigations, electronic systems, databases, and root cause analysis.
Microsoft Office, Smartsheet, 5-WHY, Ishikawa Diagram, Fishbone Analysis, Process Flow Diagram
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Principal Clinical Quality Assurance Specialist
Marlborough, Massachusetts, United States
$117k-$222k/yr HybridFull Time
5+ YOEBachelor's degree in science/engineering/health-related field, 5+ years clinical QA or clinical research compliance experience, 5+ years conducting GCP/regulatory audits, knowledge of ISO 14155/13485/GCP/GMP/GDP, CAPA and quality systems experience.
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Data Quality & Service Design Specialist
Boston, Massachusetts, United States
$72k-$104k/yr HybridFull Time
3+ YOEMinimum 3 years EDP experience including 1 year systems analysis; ability to collect user requirements, write specs and test plans; familiarity with SaaS, workforce development programs, federal/state reporting, and testing/documentation.
SaaS, CRM, analytics platforms, Microsoft Office, SharePoint, Teams
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Senior Compliance Specialist
Hopkinton, Massachusetts, United States
$80k-$110k/yr OnsiteFull Time
5+ YOEBachelor's degree with 8+ years or master's degree with 5+ years of relevant experience, plus 5+ years leading GMP quality systems, deviations, investigations, CAPAs, and change controls.
Ishikawa, 5 Whys, 6Ms, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, electronic Quality Management Systems (eQMS), FMEA, FASEP, Lean Six Sigma
2d
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Compliance and Operations Specialist
Westborough, Massachusetts, United States
$95k-$135k/yr OnsiteFull Time
3+ YOERequires BS with 8+ or MS with 4+ years in life sciences, biotechnology, biological sciences, or quality systems; 3–5 years in regulated environments; GMP, documentation, quality systems, and coordination experience.
TrackWise Digital (TWD), Veeva
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Quality Improvement Specialist Registered Nurse $5,000 retention bonus
Providence, Rhode Island, United States
OnsiteFull Time
3+ YOERhode Island RN licensure, 3–5 years of community behavioral health nursing experience, nursing degree, driver's license, insured vehicle, analytical skills, and proficiency with electronic health records and data reporting systems.
electronic health records, data reporting systems, Plan-Do-Study-Act (PDSA), Root Cause Analysis (RCA), Continuous Quality Improvement (CQI)
2w
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Manufacturing Operation and Compliance Specialist
Billerica, Massachusetts, United States
OnsiteFull Time
5+ YOERequires a high school diploma, 5+ years supporting manufacturing or quality departments, and knowledge of GMP, quality systems, CAPAs, change controls, deviations, documentation, and compliance reporting.
Track Wise, EDMS, MasterControl
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