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.
Sheffield Pharmaceuticals: Manufacturer of over-the-counter pharmaceuticals and personal care products.
Maintain QA documentation, review batch records, coordinate CAPAs and audits. Requires attention to detail, knowledge of cGMP and good documentation practices, and proficiency with Word, Excel, and PowerPoint.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
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
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.
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.
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, 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)
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