343 fda jobs at 161 companies in Pennsylvania
1w
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FDA Inspection Readiness & Front-Room Training Consultant
Pittsburgh or India
FieldFull Time
Former medical-device FDA investigator with current FDA inspection and QMS experience, front-room coaching expertise, inspection-package review skills, and international travel availability.
Quality Management System (QMS)
2d
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Role Title: Associate Director, Radiology IND/IDE Support Office
Philadelphia, Pennsylvania, United States
$81k/yr HybridFull Time
7+ YOEBachelor's degree in a scientific or related discipline and 7–10 years as a monitor or equivalent experience. Requires FDA-regulated clinical research experience with IND/IDE studies and knowledge of FDA compliance requirements.
FDA, Good Clinical Practice (GCP), Trial Master File, case report forms
2d
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Role Title: Associate Director, Radiology IND/IDE Support Office
Philadelphia, Pennsylvania, United States
$81k/yr HybridFull Time
7+ YOEBachelor's degree in a scientific or related discipline and 7–10 years as a monitor or equivalent experience. Requires FDA-regulated IND/IDE research, FDA regulations, GCP, regulatory compliance, and clinical research operations expertise.
FDA, Good Clinical Practice (GCP), Trial Master File, case report forms, risk-based monitoring
2mo
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Packaging Mechanic - 2nd Shift
Bethlehem, Pennsylvania, United States
OnsiteFull Time
1+ YOESet up, maintain, troubleshoot packaging and labeling equipment; perform preventive maintenance; ensure compliance with FDA/cGMP; document procedures.
Microsoft Office, cGMP, FDA regulations, ISO guidelines
3mo
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Director, Manufacturing Quality, GIS (Japan Based) (Center Valley, PA, US, 18034-0610)
Center Valley or Aizu
$135k-$189k/yr OnsiteFull Time
10+ YOE10+ years quality experience in regulated environment; FDA QSR/ISO 13485 knowledge; ASQ preferred; must relocate for Japan assignment.
FDA QSR, ISO 13485, MDR, CAPA, DHF, DMR, DHR
3mo
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Molding Department Area Leader - D Shift 2-2-3 - 12 hr Night shift Schedule
Clinton, Pennsylvania, United States
$24-$40/hr OnsiteFull Time
3+ YOELead GMP manufacturing team; 3–5 years GMP environment; ensure safety, quality, and productivity; strong GMP/GDP/FDA/ISO13485 knowledge.
GMP, GDP, FDA, ISO 13485, cleanroom, PPE
1w
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Manager Operations - 2nd Shift
Bethlehem, Pennsylvania, United States
OnsiteFull Time
5+ YOERequires a bachelor's degree in a technical discipline or 5 years of related experience in an FDA-regulated medical or pharmaceutical industry, plus supervisory and production management expertise.
FDA
1w
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Quality & Compliance Manager
New Britain or Exeter or Seabrook
OnsiteFull Time
5+ YOERequires 5+ years in senior medical device or pharmaceutical quality assurance, FDA or Notified Body inspection experience, people management, advanced Microsoft Office, and fluent English.
Microsoft Office, FDA, ISO 13485
1w
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QA Associate Technical & Regulatory
Elgin or Fairfield or Arizona or Arkansas or California or Colorado or Connecticut or Florida or Georgia or Hawaii or Illinois or Minnesota or Nevada or New Jersey or New York or Ohio or Pennsylvania or South Carolina or Tennessee or Texas or Washington or Wyoming or Wisconsin
$28-$34/hr RemoteFull Time
Schuman Cheese: Imports, produces, and distributes specialty cheese products.
1+ YOEBachelor's degree preferred; 1–3 years in quality assurance, regulatory, or technical work in manufacturing or food production; knowledge of FDA, USDA, HACCP, GMP, or FSMA and Microsoft Office proficiency.
FDA, USDA, HACCP, GMP, FSMA, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Outlook
3w
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Packaging Engineer
Summit or Fort Washington
$71k-$107k/yr OnsiteFull Time
5+ YOERequires 5–7 years of professional experience; bachelor's degree in packaging engineering preferred. Experience with packaging validation, specifications, component development, skin care or cosmetics, FDA, or GMP preferred.
FDA, GMP
1mo
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Food Service Employee
Philadelphia, Pennsylvania, United States
$19/hr OnsiteFull Time
High school diploma or equivalent; ability to work in cold, standing for long periods; follow food safety (USDA/FDA/HACCP), use kitchen equipment, basic math and English communication.
HACCP, USDA, FDA, meat slicer, mobile shelving
6d
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President and General Manager, Interventional
Wayne, Pennsylvania, United States
OnsiteFull Time
15+ YOEBachelor’s degree and 15 years in medical devices with increasing responsibility and commercial experience. Requires interventional market expertise, Class 3 PMA experience, clinical trials, FDA panels, and CMS reimbursement knowledge.
R&D, P&L, FDA, CMS, Global Supply Chain (GSC), Quality Assurance and Regulatory Affairs (QARA)
4d
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Refining Operator - Weekend Night Shift - $23/hr +$5 Shift Differential
East Greenville, Pennsylvania, United States
$23/hr OnsiteFull Time
High school diploma or equivalent preferred; ability to operate and adjust machinery, perform quality checks, handle materials up to 50 pounds, and follow OSHA, GMP, FDA HACCP, and allergen management requirements.
FDA, HACCP, OSHA, GMP
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
1mo
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Risk Management Associate I
Malvern, Pennsylvania, United States
$75k-$85k/yr OnsiteFull Time
4+ YOEBachelor's in life sciences, 4+ years in FDA-regulated industry with quality/regulatory compliance experience; knowledge of ISO 13485/14971 and FDA QSR; strong communication, leadership, project and database skills.
1mo
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Associate Director, REMS Operations
Parsippany or West Chester
$159k-$194k/yr HybridFull Time
7+ YOE2+ MgmtBachelor's degree, 7+ years program/project experience in regulated industry (pharma preferred), 2+ years interacting with FDA, vendor and budget management, FDA regulatory knowledge, MS Office and project tools proficiency, leadership experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project, Microsoft 365
3w
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Site Leader (Director), Operations Quality Assurance-Ultrasound
Reedsville, Pennsylvania, United States
$162k-$258k/yr OnsiteFull Time
10+ YOE10+ years leadership in FDA-regulated medical device manufacturing; deep knowledge of FDA, ISO 13485, ISO 14971, MDSAP, EU MDR; experience with quality systems, CAPA, audits, and quality transformation; Bachelor's degree required.
1mo
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Regulatory Manager
Charleroi, Pennsylvania, United States
OnsiteFull Time
Knowledge of USDA and FDA food regulatory requirements, HACCP, SSOPs, GMP, audit and inspection experience, documentation and training skills.
1mo
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PM Maintenance Mechanic (Tuesday-Friday, 6am-4pm) **$25hr**
Hazleton, Pennsylvania, United States
$25/hr OnsiteFull Time
Perform preventive and corrective mechanical maintenance, troubleshoot equipment issues, perform changeovers, and follow GMP/FDA/ISO and safety procedures.
1w
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Quality Engineer II
Quakertown, Pennsylvania, United States
OnsitePart Time
3+ YOEBachelor's in engineering or 3+ years relevant experience; knowledge of QMS, FDA and international regulations, process validation, CAPA and Microsoft Office.
Microsoft Office
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