102 fda jobs at 55 companies in Avon, IN
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
1mo
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Corporate Quality Senior Analyst
Indianapolis or United States or Canada or North America
$89k-$107k/yr HybridFull Time
1+ YOEBachelor's in science/engineering required, 1+ years related quality systems experience, familiarity with FSMA and FDA 21 CFR, ISO 22000 preferred, problem-solving and root-cause analysis skills, ability to travel across North America.
FSMA, FDA 21 CFR, ISO 22000, GFSI, FSSC 22000
2mo
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Quality Supervisor, Life Science Division 2nd shift
Whitestown, Indiana, United States
OnsiteFull Time
3+ YOELead quality team in raw material sampling; ensure GMP/FDA compliance; manage quality systems and audits; drive continuous improvement.
LIMS, Raman, Calipers, Go/No Go gauges, Microsoft Office
4d
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Engineer, Process - Drug Substance
Bloomington, Indiana, United States
OnsiteFull Time
2+ YOEBachelor's in related field and minimum 2 years project engineering experience; experience with bioprocess equipment, troubleshooting, SOPs, validation, and FDA GMP expectations.
3mo
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BL1 Utility 1st Shift
Indianapolis, Indiana, United States
$19/hr OnsiteFull Time
Minimum: experience in production/manufacturing environment; Preferred: high school or equivalent, food processing/packaging, automated machinery, USDA/FDA/GMP compliant environment.
2mo
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Medical Screener (Indianapolis, IN, US, 46241)
Indianapolis, Indiana, United States
OnsiteFull Time
1+ YOEHigh school diploma; 1+ year customer service; Louisiana Clinical Laboratory Personnel license; flexible hours; familiar with FDA, cGMP, OSHA a plus.
NDDR, CDCS, Vital signs equipment
1w
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Production Manager
Fishers, Indiana, United States
OnsiteFull Time
Plan and control medical-grade injection molding and automated assembly production, ensure ISO/FDA/GMP compliance, lead continuous improvement, and supervise production staff.
ERP, MRP, Microsoft Office
6d
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QA TECHNICIAN 1
Mooresville, Indiana, United States
$20/hr OnsiteFull Time
High school diploma, familiarity with cGMP/FDA/OTC standards, batch record review and release experience, strong attention to detail, communication, and eQMS/ERP proficiency.
Microsoft Office Suite, Red Prairie, SAP, AS400, Dynamic 365, Oracle, Intelex, MasterControl, Harford, LIMS, Labware, Specright
2w
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Environmental Health and Safety Specialist
Brownsburg, Indiana, United States
OnsiteFull Time
1+ YOESupport EHS for radiopharmaceutical manufacturing ensuring compliance with NRC, FDA, DOT, OSHA, EPA; perform radiation safety, inspections, incident investigations, training, and records management.
2w
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Plasma Center Paramedic – EMT-P
Bloomington, Indiana, United States
$23-$32/hr OnsiteFull Time
2+ YOEState EMT-Paramedic license, CPR/AED, basic IV therapy, FDA-approved Medical Support Specialist training, and 2 years clinical or hospital experience.
1w
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Process Engineer 2
Indianapolis, Indiana, United States
$67k-$101k/yr OnsiteFull Time
4+ YOEBachelor's in life science or engineering, 4+ years pharmaceutical operations experience, knowledge of US/EU GMP and FDA, project management, process investigations, and equipment design.
Microsoft Visio, AutoCAD, Minitab, JMP, Microsoft Suite, Kepner-Tregoe, FMEA, PLC
4d
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Production Operator, 1st Shift
Indianapolis, Indiana, United States
OnsiteFull Time
Assemble, test, and package medical and electronic devices per procedures; attention to detail, good documentation, ability to stand/lift, and follow ISO/FDA quality requirements.
ERP
1w
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Center Operations Manager 2
Indianapolis, Indiana, United States
OnsiteFull Time
1+ YOE1+ MgmtManage daily donor center operations, ensure regulatory compliance (FDA/OSHA/CLIA/GMP), lead quality improvement, supervise staff, and support fiscal and inventory management.
office software
3w
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Quality Specialist - Dry Sweeteners
Indianapolis, Indiana, United States
OnsiteFull Time
Heartland Food Products Group: Produces and markets low-calorie sweeteners and cold brew coffee.
1+ YOEBS degree, 1+ years food manufacturing QA experience, HACCP preferred, SQF and FDA knowledge, strong QA/cGMP skills, documentation and corrective action experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
4d
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Project Manager, CQV
Indianapolis, Indiana, United States
OnsiteFull Time
7+ YOE7+ years validation/project management experience in life sciences or FDA-regulated environments, BS in engineering, strong cGMP/validation, risk assessment, technical writing, and leadership skills.
GAMP, 21 CFR Part 11, FMEA, HAZOP, Fault Tree Analysis
1mo
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CSV Engineer - Automation Engineering
Lebanon or Carmel or Indianapolis
$66k-$172k/yr OnsiteFull Time
2+ YOEB.S. in Engineering required, 2+ years in FDA-regulated environments, experience with computer system validation for automation systems, knowledge of GxP/GMP and data integrity, and authorized to work in the U.S.
DCS, SCADA, BMS, MES, Historian, Building Management System, Data Historian, Automated Storage and Retrieval System, QMS, Kneat, ALM, Valgenesis, DeltaV, Rockwell, Syncade, LabVantage, OSI PI, Site Historian, GAMP, 21 CFR Part 11
2w
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Medical Delivery Driver - CDL
Columbus, Indiana, United States
FieldFull Time
Performs deliveries of oxygen and equipment, maintains vehicle and equipment, follows DOT/FDA/OSHA standards; high school diploma, valid driver’s license, CDL and hazmat required or to be obtained.
1mo
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21GRAMS- Account Supervisor
Boston or Carmel or Chicago or Lambertville or New York City or Philadelphia or North Carolina or Pennsylvania or United States or United States or United Kingdom or Europe
$95k-$110k/yr HybridFull Time
2+ YOEBachelor's degree in business/marketing/advertising or related, 2+ years account management experience, knowledge of pharmaceutical marketing regulations (FDA), strong leadership and communication, Microsoft Office proficiency.
Microsoft Office, LinkedIn Learning
2w
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Engineer 2, Sterilization
Ellettsville, Indiana, United States
OnsiteFull Time
2+ YOEBachelor's in engineering, minimum 2 years experience, knowledge of GMP/FDA 21 CFR/ISO standards for sterilization, AutoCAD/REVIT, Microsoft Office, PLC experience, and ability to travel ~20%.
AutoCAD, REVIT/BIM, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, PLC
2w
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Product Development Engineer
Indianapolis, Indiana, United States
OnsiteFull Time
Bachelor-level engineering degree, product development experience, knowledge of FDA and ISO 13485/14971, DHF and risk management, CAD and Microsoft Office skills, strong communication and project management.
CAD, Microsoft Office Suite