American RegentTokyo Stock Exchange: 4568: Manufactures injectable pharmaceutical products for human and veterinary use.
5+ YOEBachelor's in science/engineering,5+ years QA experience in regulated environment,knowledge of FDA regulations,CAPA writing and risk management,strong analytical and organizational skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Greenfield Global: Produces high-purity alcohols, specialty solvents, and sustainable biofuels.
7+ YOEBachelor's degree, 7+ years in quality or supplier quality within a GMP/ISO regulated environment; working knowledge of ISO 9001, IPEC-PQG GMP, EXCiPACT; experience with supplier audits, supplier development, QMS, SCAR/CAPA, and risk-based supplier quality.
ISO 9001, IPEC-PQG GMP, EXCiPACT, QMS, SCAR, CAPA, Management of Change (MoC)
HyperfineNasdaq: HYPR: Develops and sells portable MRI brain imaging systems.
5+ YOELead supplier quality activities including supplier qualification, audits, NCs/CAPAs/SCARs, product release, risk management, and continuous improvement in a regulated medical device environment.
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
3+ YOEBachelor's degree, 3 years manufacturing experience, strong problem-solving and CI skills, experience with process validation, CAPA, change control, and manufacturing quality support for 24/7 operations.
Curtiss-WrightNYSE: CW: Engineers and manufactures critical components for aerospace and defense.
1+ YOEInspect materials and products, perform measurements and tests, document results, identify non-conformances, support CAPA, read blueprints, and use measuring instruments; 1-2 years inspection experience preferred.
CooperSurgicalNasdaq: COO: Manufactures medical devices for fertility and women's health.
10+ YOELead supplier quality strategy and governance in regulated medical device environments; expertise in FDA QSR, ISO 13485, EU MDR, ISO 14971, audits, CAPA/SCAR, RCA/FMEA, and supplier development.
Microsoft Office, Minitab, ERP systems, eQMS platforms
Contract Pharmacal Corp: Manufactures and packages pharmaceuticals, OTC drugs, and dietary supplements.
Provide technical leadership of quality systems, lead investigations (deviations, complaints, OOS), author protocols and CAPAs, ensure cGMP/FDA/EMA compliance, apply problem-solving methodologies, and support inspection readiness.
Registered Nurse- 2 M- Full-Time, Day Shift - 7 a- 7.30 p
Patchogue, New York, United States
$107k-$138k/yrOnsiteFull Time
NYU Langone Health: Academic medical system providing comprehensive patient care and education.
Current New York RN license, BLS required; ACLS/PALS/TNCC/TCAR/CAPA as applicable; nursing diploma/associate required; BSN preferred; strong clinical assessment, communication, and documentation skills.
Catholic Health: Integrated healthcare system providing hospital and clinical medical services.
3+ YOEBSN required; RN license and BLS and ACLS required; PALS and specialty certs (CNOR/CAPA/CPAN/RCIS) preferred; 3–5 years perioperative nursing experience; knowledge of perioperative workflows and regulatory standards.
CiplaNational Stock Exchange of India: CIPLA: Manufactures and sells generic medicines and active pharmaceutical ingredients
1+ YOEAssociate degree with GMP documentation experience, 1+ year documentation and 3+ years pharma/biotech experience preferred; proficiency in cGMP/GDP, SOPs, CAPA, deviations; MS Word/Excel and document systems experience.
Microsoft Office Suite, Microsoft Word, Microsoft Excel, SAP, MasterControl, TrackWise, Master Control
NestléSIX Swiss Exchange: NESN: Produces and sells a wide range of food and beverages.
7+ YOE7+ years in food/dietary supplement/pharma quality, strong cGMP/FDA knowledge, HACCP/GFSI experience, team leadership, QMS/CAPA/SPC expertise, SAP and Microsoft Office proficiency, ~20% travel.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, SAP
ITTNYSE: ITT: Manufactures engineered components for transportation, aerospace, and industrial markets.
5+ YOE5+ years supplier or manufacturing quality experience; ISO 9001 knowledge; ability to read GD&T and electrical schematics; root-cause analysis and CAPA experience; supplier audits and data validation skills; willingness to travel.
Yale New Haven Health: Operates a network of hospitals and healthcare facilities.
Active Connecticut RN license, ACLS/BLS/PALS required, specialty certification (CAPA/CPAN) preferred, graduate of accredited nursing program, critical care or PACU/ASU experience preferred, proficient with electronic patient records.
Director, Data Management Process, Quality & Inspection Readiness
Warren or Tarrytown or Armonk
$183k-$305k/yrHybridFull Time
RegeneronNasdaq: REGN: Discovers and manufactures medicines for serious diseases.
12+ YOE5+ MgmtBachelor's degree and 12+ years in clinical data management, 5+ years people management; expert knowledge of GCP/ICH/21 CFR Part 11, inspection readiness, CAPA, KPI/KQI frameworks, process governance and change management.
First Class Air Support: Distributes aftermarket aircraft components and provides aviation repair services.
7+ YOE3+ Mgmt7–10+ years in an FAA Part 145 repair station or aviation MRO, 3+ years leadership in quality/safety/inspection, knowledge of FAA/EASA regulations, ability to manage SMS, CAPA, audits, inspections, and airworthiness release processes.
FAA Form 8130-3, EASA Form 1, Safety Management System (SMS)
Posimech: Precision machining and mechanical assembly for aerospace and defense.
5+ YOE5+ years QC management/supervisory experience in a precision CNC machine shop, advanced blueprint reading, GD&T, CMM programming/operation, FAI/MRB/CAPA experience, working knowledge of AS9100/ISO9001; U.S. Person required.
Director, Quality Systems & Regulatory Affairs (Remote - East Coast)
Darien, Connecticut, United States
$160k-$180k/yrRemoteFull Time
CEFALY Technology: Manufacturer of wearable medical devices for migraine relief.
8+ YOERequire 8+ years QA/RA medical device experience, bachelor’s degree, eQMS ownership experience (Greenlight Guru preferred), lead audits/inspections, FDA/EU regulatory submissions, and experience with CAPA, risk management, and document control.
ITTNYSE: ITT: Manufacturer of engineered components for industrial and transportation markets.
5+ YOE5–8 years supplier or manufacturing quality experience; expertise with inspection reports, electrical test data, power electronics; ISO 9001 knowledge; GD&T and schematic reading; root cause analysis, CAPA, supplier audits; willingness to travel.
Development Scientist II, Analytical Development and Clinical QC (ADQC)
New Haven, Connecticut, United States
OnsiteFull Time
AstraZenecaLondon Stock Exchange: AZN: Global biopharmaceutical developing and manufacturing prescription medicines.
2+ YOEAdvanced MS or PhD in biochemistry/chemistry or related field, 2+ years (PhD) or 10+ years (MS) hands-on analytical development experience, cGMP/QC knowledge, LIR/CAPA investigation skills, MS Office proficiency, strong analytical and communication skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Veeva Vault (EQV), LIMS, ValGenesis, Kneat, JMP, Tableau, SAS, Microsoft SharePoint, BOX