2mo
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Director Promotional Regulatory Affairs
Wilmington, Delaware, United States
HybridFull Time
5+ YOEBachelor's in science required; 5+ years total pharma/biotech/FDA experience with 3+ years in promotional regulatory affairs or OPDP/APLB; strong knowledge of FDA promotional regulations, drug development, and labeling; experience engaging FDA.
AZAP
1mo
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Associate Director, REMS Operations (68770)
Parsippany or West Chester or United States
$159k-$194k/yr HybridFull Time
7+ YOEBachelor's degree, 7+ years program/project management in regulated industry (preferably pharma), 2+ years working with FDA, vendor management, FDA/REMS regulatory expertise, MS365 skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, MS Project, MS365, database
3w
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Director Promotional Regulatory Affairs
Gaithersburg or Wilmington
HybridFull Time
5+ YOEBachelor's in science,3+ years promotional regulatory experience,5+ years total pharma/biotech experience,knowledge of FDA OPDP/APLB and labeling,ability to lead MLR and engage with FDA.
AZAP
2mo
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Food Safety and Quality Assurance Manager (Milford, DE, US, 19963)
Milford, Delaware, United States
OnsiteFull Time
5+ YOE5+ MgmtLead FSQA department, develop and enforce safety/quality processes, ensure regulatory compliance, partner with FDA/USDA, travel as needed.
5d
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BATCHING TECHNICIAN (3572)
Millville, New Jersey, United States
$22/hr OnsiteFull Time
1+ YOEFollow batch recipes and SOPs, operate mixing and batching equipment, perform quality checks, maintain production records, and comply with GMP/HACCP/FDA standards.
2w
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Supervisor Production
Bridgeville, Delaware, United States
OnsiteFull Time
4+ YOE1+ MgmtLead production teams, manage scheduling and performance, ensure compliance with FDA/USDA and safety rules, apply LEAN, use production reports, and be proficient with Microsoft Office.
Microsoft Office
1w
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Phlebotomist
Newark, Delaware, United States
OnsitePart Time
1+ YOEPerform venipuncture and plasmapheresis, monitor donors and equipment, document donor data, follow SOPs and FDA guidelines; high school diploma and 12 months medical experience preferred.
Personal Digital Assistant (PDA), Standard Operating Procedures (SOPs), Food & Drug Administration (FDA), Electronic donor information management system
4d
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Product Quality Engineer 1
Newark, Delaware, United States
$55k-$86k/yr OnsiteFull Time
0+ YOEBachelor’s in engineering, 0-2 years experience, familiarity with FDA QSR/ISO 13485 and risk management, root cause analysis, complaint investigation, and cross-functional CAPA implementation.
1mo
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Driver - Delivery Technician - New Castle, DE
New Castle, Delaware, United States
$23-$25/hr OnsiteFull Time
1+ YOEHigh school diploma or equivalent, 1+ year related experience, minimum three years driving history, valid driver’s license, completion of driver training program, DOT/FDA compliance, English proficiency.
1w
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Regulatory Compliance Specialist (Food Labeling)
Swedesboro, New Jersey, United States
OnsiteFull Time
2+ YOEBachelor's in food science/nutrition/regulatory field, 2+ years food industry labeling/regulatory experience, knowledge of FDA 21 CFR, ingredient/allergen/nutrition labeling, strong documentation and project skills.
Microsoft Office, TraceGains
1w
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EHS Specialist
Newark or Wilmington or Spring House
$82k-$110k/yr HybridFull Time
7+ YOEBachelor's in a scientific field, minimum 7 years EHS experience in pharmaceutical or industrial settings, strong knowledge of FDA/OSHA/EPA/ICH/GDP/DNREC/PADEP regs, strong communication and problem-solving skills.
5d
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BATCHING TECHNICIAN
Millville, New Jersey, United States
$22/hr OnsiteFull Time
1+ YOEHigh school diploma, 1+ year manufacturing or food processing experience preferred; strong math, communication, GMP/OSHA adherence; able to lift up to 60 lbs and follow SOPs for batching and quality control.
GMP, HACCP, FDA, SQF
1w
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Front End Lead
Cambridge, Maryland, United States
$34/hr OnsiteFull Time
2+ YOEHigh school diploma, minimum 2 years food manufacturing experience (aseptic preferred), leadership and training ability, knowledge of HACCP/FDA food safety, able to lift 50 lbs and work in temperature-controlled environments.
3w
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Specialty Gas Filler/Lab Technician - New Castle
New Castle, Delaware, United States
OnsiteFull Time
2+ YOEPerform specialty gas cylinder filling and testing per DOT/FDA/industry standards; forklift operation; attention to detail and safety; ability to lift up to 75 lb; Associate degree or 2 years relevant experience preferred.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft Access
1w
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EHS Specialist
Newark or Wilmington or Spring House
$82k-$110k/yr OnsiteFull Time
7+ YOEBachelor of Science in a scientific field, 7+ years EHS experience in pharmaceutical or industrial settings, knowledge of FDA/OSHA/EPA and regional regulators, respirator use, strong communication and problem-solving skills, legally eligible to work in the USA.
1mo
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Director / Associate Director Companion Diagnostics Lead, Translational Sciences
Wilmington, Delaware, United States
OnsiteFull Time
7+ YOEBS in a scientific discipline with 7+ years in diagnostics or pharmaceutical industry; experience with CDx strategy, vendor management, assay evaluation (NGS, PCR, IHC), regulatory knowledge (US FDA, EU IVDR), GCP familiarity, and strong communication.
Next Generation Sequencing, PCR, Immunohistochemistry
1mo
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QC Metrologist
Pennsville, New Jersey, United States
$82k-$105k/yr OnsiteFull Time
5+ YOEB.S. or advanced science degree and 5+ years metrology experience in a pharmaceutical environment; Agilent HPLC/GC maintenance training; cGMP/USP/EP/FDA expertise; calibration, troubleshooting, reference standards, Empower and Microsoft Office proficiency.
Agilent HPLC, Agilent GC, Microsoft Office Suite, Microsoft Excel, Microsoft Word, Empower
1mo
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Plant Engineer
Wilmington, Delaware, United States
OnsiteFull Time
1+ YOEBachelor's in science/engineering/pharmaceutical, 1–5 years chemical or pharmaceutical manufacturing, cGMP experience (ISO 9001, FSSC22000, IPEC, or FDA QMS), ability to respond to site emergencies, support Allen-Bradley PLC, support audits.
Allen-Bradley PLC
1w
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Warehouse Operations Supervisor
Woolwich Township, New Jersey, United States
$62k-$83k/yr OnsiteFull Time
1+ YOESupervisory experience (1+ years) or bachelor's in supply chain/business, WMS (Manhattan) and Microsoft Office proficiency, knowledge of OSHA/DOT/HAZMAT/FDA rules, ability to lift 50 lbs and stand 10-12 hours, flexible schedule.
Warehouse Management Systems, Manhattan, Microsoft Office
2mo
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Production Worker I
Milford, Delaware, United States
OnsiteFull Time
Operate and maintain production and packaging equipment, perform filling/labeling/inspection/packaging, follow SOPs/GMP/FDA/QA, read safety and procedure documents, perform basic math; HS/GED preferred and 6 months production experience preferred.
scales, hand jacks, powered jacks, statistical process control