94 capa jobs at 64 companies in Manhattan, NY
1d
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Manager, R&D Quality Audits, Inspections and CAPA
Foster City or Thousand Oaks or El Segundo or Santa Monica or Parsippany
$136k-$176k/yr HybridFull Time
4+ YOERequires PharmD/PhD with relevant experience, master's/MBA plus 4+ years, or bachelor's plus 6+ years in quality and compliance. Strong GCP/GVP auditing, CAPA, inspection readiness, analytical, communication, and project skills.
Microsoft Office
2mo
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Senior Quality Engineer, CAPA (Wayne, NJ) (Wayne, NJ, US)
Wayne, New Jersey, United States
$115k-$130k/yr HybridFull Time
5+ YOEBachelor's in engineering or science required, 5+ years managing CAPA processes, proficiency with TrackWise, Minitab and Microsoft Office, knowledge of ISO 13485 and FDA 21 CFR Part 820, strong root-cause analysis and auditing skills.
TrackWise, Minitab, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
1mo
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Quality Control Manager
Perth Amboy, New Jersey, United States
$100k-$115k/yr OnsiteFull Time
5+ YOEDevelop and lead quality strategy, manage quality team, maintain QMS, oversee inspections, analyze defects and drive CAPA, and lead continuous improvement in manufacturing.
QMS, ISO 9001, SPC, Lean, Six Sigma, FMEA, CAPA, CMM
4w
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Staff Design Quality Engineer
Leesburg or Allendale
$110k-$130k/yr HybridFull Time
4+ YOEBachelors in science/engineering required, 4+ years in medical device or regulated industries, experience with design controls, risk management, V&V, CAPA, and quality tools; MS/CQE/CRE and Six Sigma preferred.
FMEA, GD&T, Root Cause Analysis, Minitab, Microsoft Office, CAD, CAPA, Mistake Proofing
1mo
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Operations - Quality Engineering Lead
San Francisco or New York City
OnsiteFull Time
8+ YOE8+ years in quality program or product quality roles; experience across NPI and manufacturing quality; deep knowledge of FMEA, SPC, CAPA, 8D, Six Sigma; strong cross-functional leadership and problem-solving skills; experience with robotics or hardware preferred.
FMEA, SPC, CAPA, 8D, Six Sigma, HIL, SIL, HALT, HASS, AI agents and tools
1mo
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Supplier Quality Manager
Brookfield or Danbury
OnsiteFull Time
7+ YOEBachelor's degree, 7+ years in quality or supplier quality within a GMP/ISO regulated environment; working knowledge of ISO 9001, IPEC-PQG GMP, EXCiPACT; experience with supplier audits, supplier development, QMS, SCAR/CAPA, and risk-based supplier quality.
ISO 9001, IPEC-PQG GMP, EXCiPACT, QMS, SCAR, CAPA, Management of Change (MoC)
2mo
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Senior Auditor, Auditing and Due Diligence
Morristown, New Jersey, United States
$135k-$142k/yr HybridFull Time
10+ YOEPlan and execute GxP audits; document findings and CAPA; collaborate with multiple departments; travel 40-50% in North America.
Microsoft Office
1w
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Quality Manager – Fossil Americas
Atlanta or Toronto or Detroit or Boston or Bangor or New York City or Schenectady
$94k-$156k/yr RemoteFull Time
Bachelor's in engineering or related, proven quality experience in manufacturing/field service, expertise in nonconformance, RCA/CAPA and continuous improvement, willingness to travel ~10–30%.
PowerNow Platform
1mo
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Microbiologist (Micro) I, II, & III
Piscataway, New Jersey, United States
$70k-$95k/yr OnsiteFull Time
0+ YOEBachelor's in science/engineering, 0+ to 5+ years microbiology experience in cGMP biologics/biosimilars manufacturing (level-dependent). Knowledge of cGMP, deviation/CAPA, validation desired.
3w
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TRD QA CGT Modality Head
East Hanover, New Jersey, United States
$176k-$328k/yr OnsiteFull Time
Provide global QA leadership for CGT modality, ensure GxP compliance, oversee audits/inspections, manage deviations/CAPA, and lead quality risk management and people.
2d
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Sr. Specialist, 880 Non Sterile Safety & Quality Compliance Operations (Onsite)
Rahway, New Jersey, United States
$117k-$184k/yr OnsiteFull Time
4+ YOEBachelor's in engineering/life sciences/chemistry,4+ years pharmaceutical/GMP manufacturing,experience with investigations/CAPAs/audits,cGMP knowledge,strong communication and project skills.
Veeva, SAP, MPS
4w
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Staff Quality Systems Specialist I
Franklin Lakes, New Jersey, United States
$136k-$217k/yr OnsiteFull Time
8+ YOEBS in engineering or science,8+ years medical device/biologic/pharmaceutical/diagnostic experience,knowledge of 21CFR820,ISO13485,MDR/MDD,MDSAP,audit and CAPA expertise.
Trackwise
3w
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TRD QA CGT Modality Head
East Hanover, New Jersey, United States
$176k-$328k/yr OnsiteFull Time
Lead global QA for CGT modalities ensuring GxP compliance, audit and inspection readiness, risk management, deviation and CAPA oversight, people management, and regulatory guidance.
1mo
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Director, Quality Assurance
East Brunswick, New Jersey, United States
$170k-$200k/yr OnsiteFull Time
10+ YOEBachelor's in a scientific discipline; 10+ years QA leadership in cGMP-regulated pharmaceutical manufacturing (OSD) with inspection, validation, CAPA, and supplier oversight; proficiency with eQMS and Microsoft Office.
Electronic Quality Management Systems (eQMS), Microsoft Office Suite
3mo
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Quality Assurance Engineer II
Plainsboro, New Jersey, United States
$71k-$98k/yr OnsiteFull Time
3+ YOEBachelor’s degree in science or engineering; 3-5+ years QA experience in medical device/pharmaceutical manufacturing; strong investigations, root-cause analysis, CAPA, and regulatory knowledge.
MS Office, Statistical software
2d
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External Manufacturing Quality Lead
Guelph or Summit
HybridFull Time
6+ YOEBachelor's degree or equivalent, 6+ years GMP experience, CAPA and investigation ownership, cGMP knowledge, MS Word/Excel/PowerPoint proficiency, ability to lead cross-functional teams.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
1w
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Global Repair & Quality Manager
Elmsford, New York, United States
$90k-$110k/yr OnsiteFull Time
8+ YOE8+ years in quality/repair/ supplier or manufacturing quality; experience building QA/QMS, ISO 9001 knowledge, leading NCR/MRB/CAPA, supplier quality, and team leadership.
ERP, RMA, QMS, BI, service-management systems
1mo
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QA Specialist
East Windsor, New Jersey, United States
$72k-$81k/yr OnsiteFull Time
3+ YOE3+ years GMP experience, strong attention to detail, documentation and SOP authorship, review of deviations/CAPA, proficiency with Microsoft Office and SharePoint/Visio/Oracle, audit support and metrics tracking.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, SharePoint, Visio, Oracle
3w
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Quality Control Specialist (Weekend) (5551)
Cranbury, New Jersey, United States
$60k-$96k/yr OnsiteFull Time
1+ YOEPerform GMP sampling and QC testing of environmental, water, gas, and raw material samples; document results, investigate OOS/OOL, support CAPA and validation; proficiency with lab software and English.
TOC, Empower, TrackWise, Master Control, LES, LIMS, lab notebook
2w
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Supervisor, Quality Assurance
Piscataway, New Jersey, United States
OnsiteFull Time
1+ YOE1+ MgmtSupervisory QA role requiring pharmaceutical/manufacturing experience (1+ years with BA/BS or more for other credentials) and knowledge of cGMP; responsible for CAPA, audits, SOPs, and batch record oversight.
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