115 capa jobs at 74 companies in Pennsylvania
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Early Access Program Quality Assurance Consultant
Pennsylvania, United States
RemoteContract
QA oversight of GCP/GMP/GVP, risk assessment, CAPA, audits, regulatory filings, and QA documentation.
GCP, GMP, GVP, SOP, CAPA
6d
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Dir, Quality Assurance
Exton, Pennsylvania, United States
HybridFull Time
10+ YOEBachelor's degree or equivalent experience and 10+ years in quality assurance or regulated laboratory operations, with expertise in GMP, GLP, ISO, investigations, CAPA, audits, and data integrity.
ALCOA+, CAPA, Quality Management System (QMS), Standard Operating Procedures (SOPs), Microsoft Excel
1w
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Quality Manager
Portersville, Pennsylvania, United States
OnsiteFull Time
5+ YOEBachelor's degree in engineering or a related technical field; 5+ years of manufacturing quality leadership; QMS, audits, RCA, CAPA, SPC, FMEA, and continuous improvement experience required.
Quality Management System (QMS), Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), Statistical Process Control (SPC), FMEA, PFMEA
2w
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Senior Specialist, Americas Product Compliance & Site Quality
Bethlehem or Canada or South America
OnsiteFull Time
5+ YOEBachelor's degree or higher and at least five years of medical device quality assurance or regulatory affairs experience, including FDA, ISO, audits, CAPA, and cross-functional work.
FDA CDRH, ISO 9001, ISO 13485, CAPA, Standard Operating Procedures (SOPs), MDR
6d
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Senior Manager, External Manufacturing MSM Operations
Irvine or Somerset or Piscataway or Titusville or Horsham or West Chester or Bridgewater or Jacksonville or Malvern or Princeton or New Brunswick or Raritan or Milpitas or Limerick
$122k-$213k/yr HybridFull Time
8+ YOEBachelor's degree and 8+ years in a regulated industry required, with cross-functional program leadership, supply chain, risk management, CAPA, root cause analysis, and global team experience.
CAPA, PMI
2d
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Quality Assurance (QA) Manager
Macungie, Pennsylvania, United States
OnsiteFull Time
3+ YOEBachelor's degree in quality, operations, chemistry, business, or related field; 3+ years in quality assurance or analytical problem-solving; experience with quality systems, RCA, CAPA, audits, or process improvement.
International Organization for Standardization (ISO), Standard Operating Procedures (SOPs), Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA), Six Sigma Green Belt, Six Sigma Black Belt
2d
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Sr. Manager, Quality Assurance Compliance
Sinking Spring, Pennsylvania, United States
OnsiteFull Time
7+ YOEBachelor's degree or equivalent experience and 7 years of relevant experience required. Fluency in English and expertise in quality systems, supplier quality, audits, cGMP, GxP, ISO, CAPA, and SOP compliance.
CAPA, SOPs, cGMP, GxP, ISO
1mo
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QUALITY MANAGER
Allentown, Pennsylvania, United States
OnsiteFull Time
8+ YOE8+ MgmtBachelor's in science/engineering/microbiology/chemistry, 8+ years progressive quality leadership in manufacturing, experience managing teams (≥8), knowledge of FDA/cGMP, audits, CAPA, SPC, ERP, and Microsoft Office.
Quality Management System (QMS), ERP systems, Microsoft Office Suite, Microsoft Excel, Microsoft Word, Microsoft Outlook, Statistical Process Control (SPC), CAPA, Lean Manufacturing, Six Sigma
6d
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Senior Manager, External Manufacturing MSM Operations
Limerick or Irvine or New Jersey or Bridgewater or Raritan or Titusville or New Brunswick or Piscataway or Princeton or Somerset or Pennsylvania or West Chester or Horsham or Malvern or Jacksonville or Milpitas
€85k-€146k/yr HybridFull Time
8+ YOEBachelor's degree and 8+ years in medical device, pharmaceutical, healthcare, or regulated industry; requires cross-functional leadership, supply chain, project management, risk mitigation, root cause analysis, and CAPA experience.
CAPA, GMP, PMI
3w
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Global Aerospace Supplier Quality Manager
Grand Prairie or Dallas or Charlotte or Pittsburgh or Seattle or Atlanta or Sylmar
HybridFull Time
8+ YOE5+ MgmtBachelor's in engineering,8+ years quality experience in aerospace/regulated manufacturing,5+ years supplier quality leadership,knowledge of AS9100/AS9145/APQP/PPAP/AS9102/CAPA/8D/FMEA/MSA/SPC,Lead Auditor preferred.
AS9100, AS9145, APQP, PPAP, AS9102, CAPA, RCCA, 8D, FMEA, MSA, SPC
3d
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Senior Manager, Packaging Operations
Philadelphia, Pennsylvania, United States
OnsiteFull Time
5+ YOE3+ MgmtBachelor's degree in engineering, mathematics, or life sciences; 5+ years in a GMP packaging environment; 3+ years of people management; serialization, resource planning, Lean Six Sigma, technical writing, deviation management, CAPA, ERP, and Microsoft Office experience.
Microsoft Office, ERP, Lean Six Sigma, CAPA, cGMP, CFR
1mo
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Quality Assurance Manager
York, Pennsylvania, United States
OnsiteFull Time
5+ YOE5+ years in quality management within manufacturing, strong root cause analysis (5 Whys, 8D, CAPA), experience with QMS and data-driven quality metrics, ability to partner cross-functionally, strong communication and continuous improvement skills, must be authorized to work in the U.S. without sponsorship.
5 Whys, 8D, CAPA, Pareto analysis, QMS tools, ERP systems, document control systems, SOPs, statistical process control, value stream analysis, kaizen, dashboards, ISO 9001
2w
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Quality Engineer II
Quakertown, Pennsylvania, United States
OnsitePart Time
3+ YOEBachelor's in engineering or 3+ years relevant experience; knowledge of QMS, FDA and international regulations, process validation, CAPA and Microsoft Office.
Microsoft Office
1mo
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Quality Systems Specialist II
Avondale, Pennsylvania, United States
OnsiteFull Time
3+ YOELead complaint investigations, return material evaluations, root cause analysis, CAPA development, risk assessments, and cross-functional improvement initiatives.
3w
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Investigator, Logistics
Bethlehem, Pennsylvania, United States
OnsiteFull Time
Leading and conducting root-cause investigations for non-conformances and complaints, authoring reports in QualityOne, designing CAPAs, collaborating with SMEs, and implementing corrective actions.
QualityOne (QMS)
3w
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Facility Quality Supervisor (412832)
Allentown, Pennsylvania, United States
$70k-$101k/yr OnsiteFull Time
2+ YOEHigh school diploma/GED and 2+ years QA experience in manufacturing or related environment; ensures compliance, manages CAPAs, and supervises QA technicians.
1mo
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Quality Assurance Supervisor
Easton, Pennsylvania, United States
OnsiteFull Time
3+ YOE3+ MgmtSupervise QA team, ensure food safety and quality systems, conduct audits, manage CAPA, and support continuous improvement in a food manufacturing environment.
Microsoft Office
4w
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Quality and Environmental Health Safety (EH&S)
Butler, Pennsylvania, United States
$56k-$66k/yr OnsiteFull Time
5+ YOEBachelor's degree or equivalent, ~5 years manufacturing quality/EH&S experience, knowledge of QMS, CAPA, audits, OSHA, strong communication and analytical skills.
1w
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Senior Clinical Trial Case Manager
King of Prussia or Maidenhead
OnsiteFull Time
7+ YOEBachelor's degree or equivalent in life sciences and 7+ years of pharmacovigilance experience in multinational pharmaceuticals; requires regulatory, GxP, inspection, data, CAPA, and SOP expertise.
4w
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SQF Practitioner
Ephrata, Pennsylvania, United States
$70k-$80k/yr HybridFull Time
HACCP and PCQI required; experience implementing and managing SQF programs in food production; supervisory experience preferred; able to perform audits, CAPAs, traceability and training.
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