58 capa jobs at 29 companies in Fishers, IN
1w
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Quality Systems Engineer III
Indianapolis or Plainfield or Quincy
$82k-$156k/yr RemoteFull Time
Bachelor's degree in engineering or a related technical field; quality engineering, process controls, CAPA, root cause analysis, continuous improvement, data analysis, communication, and cross-functional collaboration skills required.
CAPA
1w
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Quality Systems Engineer III
Indianapolis or Plainfield or Quincy
$82k-$156k/yr RemoteFull Time
Bachelor's degree in engineering or a related technical field; quality engineering, process controls, CAPA, root cause analysis, data analysis, problem-solving, communication, and cross-functional collaboration skills required.
CAPA
1mo
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Quality Manager
Indianapolis, Indiana, United States
$110k/yr OnsiteFull Time
10+ YOE5+ Mgmt10+ years quality experience in regulated manufacturing, 5+ years leadership, ISO 13485, CAPA, root cause analysis, SPC, PFMEA, Six Sigma, audit leadership; ITAR U.S. person required.
ISO 13485, CAPA, SPC, PFMEA, 8D
2d
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Quality Engineer
Franklin, Indiana, United States
$84k-$100k/yr OnsiteFull Time
7+ YOEBachelor's degree in engineering, statistics, or equivalent; 7–10 years in plant quality or continuous improvement; ISO, auditing, Lean, Six Sigma, SPC, DOE, FMEA, CAPA, and statistical analysis experience required or preferred.
PFMEA, PCPs, QMS, Lean, ISO, Six Sigma, CAPA, ISO9001, SPC, DOE, 8D, FMEA, ISO-9000, E-Verify
2mo
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QA Specialist for IQC,1st shift
Fishers, Indiana, United States
OnsiteFull Time
4+ YOEQA specialist with GMP manufacturing, IQC, batch records, deviations, CAPA, and data systems; 4+ years in pharmaceutical QC.
Veeva, SCADA, BMS, CMMS, LIMS, JMP, Minitab, Microsoft Word, Microsoft Excel, Visio
4w
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Principal Scientist Deviation Management Lilly Medicine Foundry
Indianapolis or Lebanon
$65k-$169k/yr OnsiteFull Time
3+ YOEExperience leading deviation/OOS investigations, root cause analysis and CAPA in GMP environments; BS/MS in scientific discipline; strong technical writing and troubleshooting skills.
TrackWise, Veeva QMS, FMEA
1d
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Deviation Investigator
Indianapolis, Indiana, United States
$34-$41/hr OnsiteFull Time
2+ YOEBachelor's or master's degree in a scientific, engineering, pharmaceutical, biotechnology, or related field and 2–7 years in GMP manufacturing or a regulated environment; investigation and CAPA experience preferred.
Microsoft Office, electronic quality systems, document management systems
1mo
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Quality & Compliance Manager onsite in Lebanon, IN- Life Sciences/ Pharmaceutical
Lebanon, Indiana, United States
OnsiteFull Time
3+ YOESupervisory experience with 3+ years relevant experience, knowledge of audits/CAPAs in life sciences/pharmaceutical/GMP, strong leadership, organizational and communication skills, and Microsoft Office proficiency.
Microsoft Word, Microsoft Excel, Microsoft Outlook
1mo
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Principal Technical Operations Engineer (Radiopharmaceuticals)
Indianapolis, Indiana, United States
$81k-$116k/yr OnsiteFull Time
4+ YOELead development and improvement of radiopharmaceutical manufacturing processes, manage NCRs/CAPAs and change controls, ensure compliance with ISO 13485 and 21 CFR 820, and support operations and quality functions.
1w
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Associate Director, Quality Assurance (Clinical Research Preferred)
Durham or Indianapolis or Wayne
$89k-$247k/yr RemoteFull Time
10+ YOE10+ years QA experience in pharmaceutical/biotech/CRO/clinical research, strong GxP/GCP knowledge, audit and CAPA experience, leadership, risk assessment, and Microsoft Office proficiency.
Microsoft Office
1d
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Deviation Investigator
Indianapolis, Indiana, United States
$34-$41/hr OnsiteFull Time
2+ YOEBachelor’s or master’s degree in a scientific, engineering, pharmaceutical, biotechnology, or related field, plus 2–7 years in GMP or regulated manufacturing and deviation, CAPA, and root cause investigation experience.
Microsoft Office
21h
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Manufacturing Ops Support Specialist I/II/III - Commercial
Lexington or Fishers
$65k-$105k/yr OnsiteFull Time
1+ YOEBS or MS in biology, biochemistry, molecular biology, or related field, or equivalent experience; 1–8+ years related industry experience; deviation, CAPA, change control, and biomanufacturing experience.
Event & Causal Factor Charting, Kepner-Tregoe Problem Analysis, Pareto Chart, Control Chart, Process Map, chromatography, filtrations
2w
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Quality Assurance Specialist
Clayton, Indiana, United States
$65k-$80k/yr OnsiteFull Time
3+ YOE3+ years QA experience in GMP-regulated environments; knowledge of FDA 21 CFR (111,210,211), ISO 13485, CAPA, audits, supplier quality; BS preferred; SAP and Microsoft Office proficiency.
SAP, Microsoft Excel, Microsoft Word
1mo
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Quality and Training Specialist
Whiteland, Indiana, United States
OnsiteFull Time
1+ YOE1+ years QA experience in distribution/warehouse; knowledge of ISO/QMS, AIB/GMP/FDA compliance, internal auditing, CAPA, risk assessment, training development/delivery, and Microsoft Office proficiency.
QMS, WMS, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook
1mo
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Senior QA Engineer
Greenwood, Indiana, United States
OnsiteFull Time
5+ YOE2+ MgmtBachelor's in engineering or related field,5+ years QA in manufacturing/distribution,2+ years managing quality staff,experience with ISO 13485/MDSAP/FDA,QMS,CAPA,root-cause methods.
ISO 13485, MDSAP, FDA, A3, 8D, DMAIC
2mo
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Quality Assurance Manager
Westfield, Indiana, United States
$99k-$199k/yr OnsiteFull Time
8+ YOE3+ MgmtB.S. in engineering (or equivalent), 8+ years in manufacturing-quality roles, 3+ years supervisory experience, strong project management and people leadership, nonconformance/CAPA experience, regulatory compliance, and continuous improvement skills.
1w
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Compliance Manager
Brownsburg, Indiana, United States
OnsiteFull Time
5+ YOE3+ MgmtBachelor's in chemistry/engineering,5+ years QA experience (3+ years supervisory),knowledge of GMP/FDA/EMA/ICH,document control and CAPA experience,proficiency with document management and Microsoft Office,strong communication.
Microsoft Office
1mo
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Quality Control Specialist II
Indianapolis, Indiana, United States
$22-$28/hr OnsiteFull Time
2+ YOEAAS required (BA/BS preferred) and minimum 2 years manufacturing quality experience; ability to read technical drawings; perform inspections, process audits, FAI, CAPA, NCR; recommend process improvements and train others.
PC, printer, telephone, fax machine, copier, cutting machine, vacuum chamber, scales, calipers, tape measure, digital camera
1mo
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Staff Quality Assurance Engineer
Indianapolis, Indiana, United States
OnsiteFull Time
7+ YOE7+ years quality or manufacturing engineering experience in regulated industries; apply ISO 9001/13485 and 21 CFR Part 820; process validation, CAPA, risk management, and continuous improvement; BS in engineering or science required.
Power BI, DAX, Power Query, Oracle, IQVIA, ERP, eQMS
1w
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Quality Assurance Supervisor
Clayton or Whitestown or Brownsburg
OnsiteFull Time
3+ YOE2+ MgmtBachelor's degree in engineering, science, or related field preferred; 3–5 years of quality experience in a regulated industry and 2 years of supervisory experience required. Requires quality systems, CAPA, cGMP, FDA, and audit expertise.
CQ, Tecsys Elite, WebCTRL, Microsoft Outlook, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Microsoft Office
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