Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
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.
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
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.
CaterpillarNYSE: CAT: Manufactures construction equipment, mining machinery, and industrial engines.
Early-talent role for recent or upcoming university graduates. Requires supplier quality supervision knowledge, CAPA and 8D problem solving, QMS and ISO 9001 awareness, analytical skills, and professional communication.
Principal Scientist Deviation Management Lilly Medicine Foundry
Indianapolis or Lebanon
$65k-$169k/yrOnsiteFull Time
Eli Lilly and CompanyNYSE: LLY: Researches and manufactures medicines for human health.
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.
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
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
Quality & Compliance Manager onsite in Lebanon, IN- Life Sciences/ Pharmaceutical
Lebanon, Indiana, United States
OnsiteFull Time
CBRENYSE: CBRE: Provides global commercial real estate services and investment management.
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
Principal Technical Operations Engineer (Radiopharmaceuticals)
Indianapolis, Indiana, United States
$81k-$116k/yrOnsiteFull Time
Cardinal HealthNYSE: CAH: Distributes pharmaceuticals and manufactures medical products for healthcare providers.
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.
Associate Director, Quality Assurance (Clinical Research Preferred)
Durham or Indianapolis or Wayne
$89k-$247k/yrRemoteFull Time
IQVIANYSE: IQV: Provides clinical research and healthcare data analytics services.
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.
Manufacturing Ops Support Specialist I/II/III - Commercial
Lexington or Fishers
$65k-$105k/yrOnsiteFull Time
Genezen: Produces viral vectors for cell and gene therapy programs.
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
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.
Aurora or Indianapolis or Grand Rapids or Dayton or Milwaukee
$100k/yrOnsiteFull Time
Versiti: Non-profit provider of blood collection, diagnostic testing, and research.
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
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
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.
Orano: Specialist in the nuclear fuel cycle and nuclear medicine.
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.
LifeScience Logistics: Provides healthcare logistics and temperature-controlled pharmaceutical warehousing.
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
DanaherNYSE: DHR: Develops scientific instruments and diagnostic tools for healthcare markets.
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
AeroSafe Global: Provides temperature-controlled logistics and reusable packaging for biopharmaceuticals.
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
Venture Logistics: Asset-based trucking, warehousing, and supply chain management services.
2+ YOEMaintain QMS, perform audits, manage CAPA and root cause analysis, support warehouse quality and inventory accuracy; 2+ years quality/logistics experience preferred; ISO 9001:2015 knowledge; associate/bachelor preferred.
IMMI: Designs and manufactures advanced safety systems for vehicles.
2+ YOE2+ years QA/auditing experience preferred; knowledge of IATF 16949 and ISO 9001; ability to conduct audits/inspections, use precision measurement instruments, support CAPA and continuous improvement, and work with ERP/MES and quality tools.
Oracle, SAP, Plex, Minitab, Microsoft Excel, Microsoft Office Suite, SPC software, FMEA, PPAP, MSA, CMM, calipers, micrometers, gauges, Smartsheet, Microsoft SharePoint, QMS platforms
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
8+ YOE3+ MgmtB.S. in Engineering or equivalent; 8+ years manufacturing-quality experience with 3+ years supervisory experience; strong project management, CAPA, regulatory compliance, and people leadership skills. Medical device and Six Sigma/ASQ credentials preferred.