Englert: Manufacturer of metal roofing and seamless gutter systems.
5+ YOEDevelop and lead quality strategy, manage quality team, maintain QMS, oversee inspections, analyze defects and drive CAPA, and lead continuous improvement in manufacturing.
QMS, ISO 9001, SPC, Lean, Six Sigma, FMEA, CAPA, CMM
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/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
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.
Amneal PharmaceuticalsNASDAQ: AMRX: Develops and manufactures generic and specialty pharmaceutical products.
1+ YOEBachelor's degree in engineering, pharmaceutics, industrial pharmacy, or related field; 1+ year of relevant experience; process validation, manufacturing, statistical analysis, SOP, RCA, CAPA, FDA, and cGMP knowledge.
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/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
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.
MaerskNasdaq Copenhagen: MAERSK B: Operates container ships and provides global logistics services.
Experience implementing and maintaining QMS and ISO 9001, audit and CAPA management, process improvement, training, SOP creation, and SharePoint/workflow development.
MaerskNasdaq Copenhagen: MAERSK B: Provides global integrated container logistics and supply chain services.
Maintain and improve QMS and ISO compliance, lead audits, manage CAPA, train sites, implement continuous improvement and support quality KPI objectives.
Kashiv BioSciences: Develops biosimilars and drug delivery systems for medicine improvement.
0+ YOEBachelor's in science/engineering, 0+ to 5+ years microbiology experience in cGMP biologics/biosimilars manufacturing (level-dependent). Knowledge of cGMP, deviation/CAPA, validation desired.
Merck & Co.NYSE: MRK: Develops and manufactures prescription medicines, vaccines, and animal health products.
4+ YOEBachelor's degree in engineering, life sciences, chemistry, or related field; 4+ years of pharmaceutical or GMP manufacturing experience; experience with investigations, CAPAs, audits, and quality systems.
Merck & Co.NYSE: MRK: Produces prescription medicines, vaccines, and animal health products.
4+ YOEBachelor's in engineering/life sciences/chemistry,4+ years pharmaceutical/GMP manufacturing,experience with investigations/CAPAs/audits,cGMP knowledge,strong communication and project skills.
Avet Pharmaceuticals: Manufactures and distributes generic and specialty pharmaceutical products.
10+ YOEBachelor's in a scientific discipline; 10+ years QA leadership in cGMP-regulated pharmaceutical manufacturing (OSD) with inspection, validation, CAPA, and supplier oversight; proficiency with eQMS and Microsoft Office.
Electronic Quality Management Systems (eQMS), Microsoft Office Suite
Integra LifeSciencesNASDAQ: IART: Manufacturing surgical instruments and regenerative medical technology devices.
3+ YOEBachelor’s degree in science or engineering; 3-5+ years QA experience in medical device/pharmaceutical manufacturing; strong investigations, root-cause analysis, CAPA, and regulatory knowledge.
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
1+ YOEExperience in GMP/QMS, ISO standards, internal/external audits, CAPA and deviation management; strong technical writing, analytical and communication skills; ability to work in cleanroom environments.
TrackWise, OCPLM, Master Control, Microsoft Office, Microsoft Excel, PowerBI
EugiaNSE: ARBN: Manufactures and distributes generic sterile injectables and oncology medications.
10+ YOEBachelor's degree in a scientific discipline and 10+ years in Quality Compliance, Quality Systems, or GxP programs. Requires leadership, FDA inspection, audit, CAPA, vendor oversight, and Pharmacovigilance experience.
Quality Systems, Safety Data Exchange Agreements (SDEAs)
Eugia: Developer and manufacturer of generic sterile injectable pharmaceuticals.
3+ YOE3+ years GMP experience, strong attention to detail, documentation and SOP authorship, review of deviations/CAPA, proficiency with Microsoft Office and SharePoint/Visio/Oracle, audit support and metrics tracking.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, SharePoint, Visio, Oracle
WuXi BiologicsHong Kong Stock Exchange: 2269: Provides discovery, development, and manufacturing services for biologic drugs.
1+ YOEPerform GMP sampling and QC testing of environmental, water, gas, and raw material samples; document results, investigate OOS/OOL, support CAPA and validation; proficiency with lab software and English.
CareTria: Integrated platform for pharmaceutical therapy initiation and patient support.
4+ YOE4+ MgmtBachelor's in engineering/life sciences or 10+ years related experience; 4+ years GxP leadership; expertise in cGMP/GDP, internal and client/regulatory audits, CAPA, and cross-functional process improvement.
Catalent: Global provider of drug development and manufacturing solutions.
7+ YOE3+ Mgmt7+ years GMP experience in pharma/biologics/cell therapy, 3+ years supervisory experience, Bachelor's in science/engineering required, QA operations, batch review, deviation/CAPA/change control expertise.
Rocket PharmaceuticalsNASDAQ: RCKT: Developing gene therapies for rare and life-threatening diseases.
5+ YOEBachelor’s degree or equivalent experience and 5–8 years supporting IT systems in GxP-regulated environments; knowledge of GAMP 5, 21 CFR Part 11, CSV, change control, CAPA, and audit readiness.
Legend BiotechNASDAQ: LEGN: Develops cell therapies for the treatment of cancer.
12+ YOEBachelor's in scientific/technical discipline required; 12+ years GxP quality/compliance experience with 5+ years leadership; experience with audits/inspections, CAPA, change control, global GxP regulations, and Microsoft Office.
Microsoft Outlook, Microsoft Excel, Microsoft Word, Microsoft PowerPoint