69 fda jobs at 40 companies in Hamden, CT

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Clinical Research Coordinator 2
New Haven, Connecticut, United States
$65k-$101k/yr OnsiteFull Time
Yale University
Yale University: Provides higher education and conducts research across various disciplines.
2+ YOECoordinate clinical trials; manage screening, eligibility, recruitment; ensure compliance with GCP, FDA, HIPAA; independent multi-study management; strong communication.
GCP, FDA Regulations, HIPAA, EMR, Clinical Trial Management Systems
1mo
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Quality Engineer (Bridgeport, CT, US, 06610-0156)
Bridgeport, Connecticut, United States
OnsiteFull Time
AMETEK
AMETEKNYSE: AME: Manufacturer of electronic instruments and electromechanical devices.
3+ YOEBachelor's in engineering, 3+ years quality experience with metrology/CMM, GD&T, SPC/DOE, ISO and FDA QSR knowledge, blueprint reading, statistical analysis, and ability to lead inspections and corrective actions.
CMM, optical comparators, micrometers, calipers, gage blocks, pin gages, Gage R&R, GD&T, DOE, SPC, ISO, FDA, ECNs, SCRs, Material Review Board (MRB)
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Operations Supervisor
Melville, New York, United States
$60k-$80k/yr OnsiteFull Time
Certified Group
Certified Group: Provides laboratory testing, regulatory consulting, and certification services.
3+ YOELead FDA sampling operations, supervise samplers, manage scheduling, ensure FDA compliance, and coordinate with laboratory and client teams. Requires 3+ years related experience and supervisory experience preferred.
Microsoft Office
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Quality Management System (QMS) Engineer
Torrington, Connecticut, United States
$70k-$100k/yr OnsiteFull Time
Aptyx
Aptyx: Manufacturer of complex components for medical and industrial applications.
3+ YOELead and maintain QMS, CAPA, NCR, audits; ensure FDA/ISO compliance in regulated medical device manufacturing.
eQMS, CAPA system, document control software
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Operations Supervisor
Windsor, Connecticut, United States
OnsiteFull Time
LifeScience Logistics
LifeScience Logistics: Provides healthcare logistics and temperature-controlled pharmaceutical warehousing.
3+ YOE3+ MgmtBachelor’s degree + 3+ years distribution/warehouse management; 3+ years supervisory; pharma warehousing and HazMat preferred; FDA/cGMP familiarity
Tecsys Elite, MQ1, Outlook, Excel, PowerPoint, TECSYS, UKG
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FSQA Quality Assurance Technician - 1st shift
Meriden, Connecticut, United States
$18/yr OnsiteFull Time
Universal Pure
Universal Pure: Provider of high-pressure processing and cold chain food services.
2+ YOEQA role in manufacturing; high school required; 2-3 years experience preferred; FDA/GMP knowledge preferred; basic Excel skills.
Excel
2w
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Principal Microbiologist
Stamford or Trumbull
$110k-$120k/yr OnsiteFull Time
Henkel
HenkelXETRA: HEN3: Manufactures laundry, beauty, and adhesive products globally.
10+ YOE10+ years industry microbiology experience with preservation, antibacterial product development, regulatory interpretation (FDA), complex study design, manufacturing microbiology, and leadership.
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Compounding Inspector
New London, Connecticut, United States
$18-$20/hr OnsiteFull Time
Sheffield Pharmaceuticals
Sheffield Pharmaceuticals: Manufacturer of over-the-counter pharmaceuticals and personal care products.
High school diploma; ability to work 3rd shift; knowledge of cGMP/FDA/GLP; basic lab skills; English proficiency; strong record-keeping.
3w
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Product Development Manager (5703)
Windsor Locks, Connecticut, United States
OnsiteFull Time
Ahlstrom
Ahlstrom: Manufacturer of sustainable fiber-based specialty materials.
Lead product development for medical films and nonwovens, oversee design transfers, manage projects and trials, understand film chemistry and FDA/ISO awareness, and travel as needed.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Teams
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QA Sr. Specialist - CAPA
Shirley, New York, United States
$80k-$95k/yr OnsiteFull Time
American Regent
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
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Sr. Manager, Quality Excellence
Hauppauge, New York, United States
$155k-$175k/yr OnsiteFull Time
Danaher
DanaherNYSE: DHR: Develops scientific instruments and diagnostic tools for healthcare markets.
7+ YOE5+ MgmtExtensive leadership in Quality, QA/QC, and manufacturing operations in FDA/EPA-regulated environments; ISO 9001/13485; Lean and Six Sigma; strong governance and QMS experience.
SAP, Oracle, Veeva, Magic
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Analytical Chemistry Quality Cooridinator
Trumbull, Connecticut, United States
$85k-$95k/yr OnsiteFull Time
UnileverLondon Stock Exchange: ULVR: Manufactures and distributes food, home, and personal care products.
3+ YOEBachelors in science (chemistry preferred) with 5+ years or Masters with 3+ years; QC lab experience, knowledge of FDA/HC/ICH, LIMS, statistical analysis, and chromatographic techniques.
Laboratory Information Management System (LIMS), LabVantage, Power BI, Microsoft Excel, JMP, SPSS, Python, R, Matlab, HPLC, GC, ChemStation, Open Lab, Empower
1w
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Scientist II; Analytical R&D
Hauppauge, New York, United States
$70k-$90k/yr OnsiteFull Time
Contract Pharmacal Corp
Contract Pharmacal Corp: Manufactures and packages pharmaceuticals, OTC drugs, and dietary supplements.
1+ YOEBachelor's or advanced degree in chemistry/analytical chemistry with pharmaceutical experience (1–7 years depending on degree). Knowledge of USP/FDA, method development/validation, and instrumentation required.
HPLC, UPLC, ICP, GC, FT-IR, UV, Dissolution, pH, TOC, Karl Fischer, Empower 1-3, EZ Chrome Elite, WindLab, ChemStation, Microsoft Word, Microsoft Excel, Microsoft Outlook
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Prin Regulatory Affairs Spec
North Haven or Mansfield or Mounds View or Boston or Lafayette
$120k-$180k/yr OnsiteFull Time
Medtronic
MedtronicNYSE: MDT: Developing and manufacturing medical technologies and therapies globally.
7+ YOEBachelor's degree and 7+ years regulatory experience (or advanced degree with 5+ years). Experience with 510(k), FDA interactions, international registrations, labeling and promotional material review.
3w
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Senior Quality Specialist (Hybrid)
Bohemia, New York, United States
$85k-$100k/yr HybridFull Time
Nestlé
NestléSIX Swiss Exchange: NESN: Produces and sells a wide range of food and beverages.
5+ YOE5+ years quality experience in manufacturing, knowledge of FDA regulations, food safety/HACCP and GMPs, project management, statistical analysis, and proficiency with Windows applications and SAP/PLM/QMS.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, SAP, Viva, PLM, QMS
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ERP Operations Analyst
Bethel, Connecticut, United States
$78k-$113k/yr OnsiteFull Time
Resonetics
Resonetics: Specializes in laser micro-manufacturing and engineering for medical devices.
7+ YOE5+ Mgmt7+ years manufacturing; 5+ years in manufacturing/inventory management; lean tools knowledge; ERP experience; FDA/GMP/ISO 13485 knowledge; strong communication and analytical skills.
Epicor ERP, QAD, Microsoft Office
3w
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Manufacturing Supervisor
Canaan, Connecticut, United States
OnsiteFull Time
BD
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
5+ YOEBachelor's degree or equivalent and 5+ years relevant experience; leadership and coaching skills; knowledge of safety, quality, FDA/GMP/ISO/OSHA; proficiency with SAP, MES and Microsoft Office.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, SAP, MES
2mo
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Production Supervisor - Components
Bethel, Connecticut, United States
$31-$46/hr OnsiteFull Time
Resonetics
Resonetics: Engineering and manufacturing solutions for medical devices.
4+ YOESupervises production staff, schedules work, trains employees, ensures safety and quality; 4+ years supervisory manufacturing experience; ISO/FDA knowledge; associates degree; bilingual preferred.
Microsoft Office, Excel, Access, Data Tracking Systems
1mo
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Engineer I, Manufacturing
Southington, Connecticut, United States
OnsiteFull Time
ICU Medical
ICU MedicalNasdaq: ICUI: Develops and manufactures medical devices for infusion and critical care.
2+ YOEBachelor's in Engineering/Technology/STEM, 2 years' medical device or engineering experience, knowledge of injection molding, automation, Six-Sigma methods, FDA QSR, SolidWorks, and technical writing.
SolidWorks
1mo
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Part-time- temporary Food Inspector (CT, South Windsor)
South Windsor, Connecticut, United States
$35/hr FieldPart Time, Temporary
Town of South Windsor
Town of South Windsor: Provides local government services and municipal administration to residents.
Conduct inspections of licensed food establishments to ensure compliance with the FDA Food Code and local health ordinances; flexible hours including evenings/weekends; mileage reimbursed for travel between inspections.