32 quality systems specialist jobs at 18 companies in Hampton, NH
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Quality Systems Specialist - CAPA
Manchester, New Hampshire, United States
OnsiteFull Time
2+ YOEAssociate or bachelor's degree preferred; 2–5 years in quality systems, quality assurance, or a regulated industry. Requires CAPA experience, ISO 13485 and FDA QSR knowledge, root cause analysis, and Microsoft Office proficiency.
Microsoft Office, electronic QMS systems, 5-Why, Fishbone, fault tree analysis
2mo
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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
2mo
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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
2mo
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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
2mo
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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
4w
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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
2mo
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Quality Systems and Training Support Specialist
Amesbury, Massachusetts, United States
$57k-$98k/yr OnsiteFull Time
HS/GED required; proficiency with Microsoft Office; experience supporting CMMS, LMS, DMS, NCM/CAPA and calibration databases; records management, report generation, strong written and verbal communication; U.S. citizenship required.
CMMS, LMS, DMS, NCM, CAPA, Microsoft Word, Microsoft Outlook, Microsoft Excel, Microsoft PowerPoint
1w
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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)
18h
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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)
1w
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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
1mo
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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.
2mo
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Senior Specialist, Field Quality QA Operations
Devens, Massachusetts, United States
$90k-$108k/yr OnsiteFull Time
4+ YOEMinimum 4 years QA experience in pharmaceutical or medical device manufacturing, batch record review experience, knowledge of US/EU cGMP, familiarity with electronic/paper batch record systems and DeltaV; bachelor's degree preferred.
DeltaV
1w
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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
1mo
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Specialist, Quality Assurance Shop Floor, Cell Therapy
Devens, Massachusetts, United States
$40-$49/hr OnsiteFull Time
2+ YOE2+ years cGMP experience (1+ year site manufacturing), ability to provide on‑the‑floor QA oversight, review batch records and deviations, support inspections, work in cleanroom environments, and use MES/SAP/Veeva systems.
MES/Syncade, SAP, Infinity, BMSDocs (Veeva), CELabs, ValGenesis, DeltaV, Maximo, Microsoft Office
3mo
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Computer Systems Validation Specialist III
Portsmouth, New Hampshire, United States
OnsiteFull Time
3+ YOEBachelor's in computer science or engineering; 3+ years CSV experience; 3+ years in a cGMP facility; experience with 21 CFR Part 11 and ISPE GAMP; background in biotech/pharma/medical devices; ability to work on-site in Portsmouth, NH.
QMS software, Documentation tools
1w
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QA Specialist II - Ops Floor Support
Bedford, New Hampshire, United States
OnsiteFull Time
3+ YOEBachelor's degree in a relevant scientific field and 3+ years of relevant GMP industry experience, including 1+ year in Quality, or equivalent experience. Requires investigations, technical writing, and quality systems experience.
FMEA, HACCP, PHA, ICH Q9
1mo
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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
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
1w
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Aquaculture Specialist I
Boston, Massachusetts, United States
$20-$29/hr OnsiteFull Time
1+ YOEHigh school diploma or GED required; 1+ year of aquaculture experience preferred. Requires fish husbandry, aquaculture system operation, water quality testing, and animal welfare observation skills.
recirculating aquaculture systems, aquatics tank washers, feeding robots, integrated electronic water quality monitoring systems
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