59 capa jobs at 30 companies in Noblesville, IN
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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
1d
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Quality Coordinator
Whitestown, Indiana, United States
OnsiteFull Time
1+ YOEAssociate degree or equivalent experience, 1–3 years in quality or manufacturing, ISO 9001:2015 expertise, internal auditing, document control, CAPA, root cause analysis, communication, and organizational skills.
Quality Management System (QMS), Standard Operating Procedures (SOPs), Nonconforming Material Reports (NCRs), Corrective and Preventive Actions (CAPA), International Organization for Standardization 9001:2015 (ISO 9001:2015), 8D, Failure Mode and Effects Analysis (FMEA), SWOT, Key Performance Indicators (KPIs), Production Part Approval Process (PPAP), Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), International Organization for Standardization 13485 (ISO 13485), FDA 21 CFR 820
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
1w
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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
1mo
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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
6d
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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.
2w
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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
5d
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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
4d
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Manager Quality Assurance
Aurora or Indianapolis or Grand Rapids or Dayton or Milwaukee
$100k/yr OnsiteFull Time
6+ YOEBachelor's degree and 6+ years of QA oversight in biological manufacturing. Requires cGMP, FDA, audit, CAPA, QMS, batch record, technical writing, data analysis, and communication experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Windows
6d
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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
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
2mo
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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
3w
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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
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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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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