3mo
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Quality Site Head
Houston, Texas, United States
OnsiteFull Time
Senior leadership in GMP quality with expertise in GxP, FDA/EMA compliance, and strategy.
GxP, GMP, FDA regulations, ISO standards
3mo
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Project Lead
Austin, Texas, United States
$87k-$173k/yr OnsiteFull Time
5+ YOEBS in Engineering or Science with Engineering, 5+ years manufacturing experience, exposure to FAI, Ppk, cGMP/FDA/ISO; strong project leadership.
cGMP, FDA, ISO, Design of Experiments, DMAIC, FAI, PpK, mold design, tooling, qualification
3mo
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Project Lead
Austin, Texas, United States
$87k-$173k/yr OnsiteFull Time
5+ YOEB.S. Engineering or Science with Engineering experience; 5+ years in manufacturing; GMP/FDA/ISO familiarity; injection molding/medical device experience preferred.
GMP, FDA, ISO, Injection Molding, Process Validation
2mo
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Senior Supplier Quality Engineer
Houston, Texas, United States
$110k-$120k/yr OnsiteFull Time
8+ YOEBachelor's degree in engineering; 8+ years quality/manufacturing engineering experience; regulated FDA medical device environment preferred; strong quality and project management skills.
Quality Management System (QMS), ISO 13485, MDSAP, FDA regulations
3mo
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Associate Director, Regulatory Affairs
Berkeley Heights or New York or Frederick or Fort Worth or Berkeley Heights
$145k-$200k/yr RemoteFull Time
7+ YOE5+ MgmtLead regulatory strategy and submissions for early to clinical development of biologics/drugs; manage regulatory documentation and interactions; ensure compliance with FDA/EU and ICH; strong leadership.
Regulatory Submissions, IND, FDA Regulations, EU Regulations, ICH Guidelines
1mo
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Center Director 1
Pasadena, Texas, United States
OnsiteFull Time
Leadership role overseeing donation center operations, regulatory compliance (FDA/OSHA/CLIA/GMP), quality and safety programs, staff management, training, and achievement of production and financial targets; bachelor’s preferred.
FDA, OSHA, CLIA, GMP, CAPA
1mo
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Quality Manager
Frisco, Texas, United States
$97k-$127k/yr HybridFull Time
8+ YOEBachelor's in food science/technology/engineering, 8+ years in food/beverage or packaging quality, working knowledge of GFSI/FDA/HACCP/PCQI, certified lead auditor experience, ability to travel domestically and internationally.
5 Why, A3, FMEA, GFSI, HACCP, PCQI, FDA
1mo
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Lab Analyst
Dallas, Texas, United States
OnsiteFull Time
2+ YOEBachelor's in a life science and 2+ years of commercial food-testing or analytical lab experience; knowledge of aseptic techniques, GLP/FDA/ISO methods; ability to follow protocols and maintain lab quality and safety.
GLP, OSHA, FDA, BAM, APHA, ISO, USP
1mo
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QC Scientist, I - Method Validation(W)
The Woodlands, Texas, United States
OnsiteFull Time
4+ YOEB.S. in a life science, 4+ years biotech/pharma/cell therapy experience, hands-on mammalian cell culture and analytical method qualification/validation experience, flow cytometry/ELISA/PCR familiarity, knowledge of cGMP/ICH/FDA.
flow cytometry, ELISA, PCR, ALCOA+, GMP, GDP, ICH, FDA
1mo
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Director, R&D Operations - Advanced Optics Technologies
Fort Worth, Texas, United States
OnsiteFull Time
10+ YOE6+ Mgmt10+ years relevant experience with deep expertise in optical engineering or vision science, 6+ years leadership, experience leading cross-functional R&D teams, portfolio and resource management, FDA/GxP knowledge, and experience with AI/ML programs and MLOps.
MLOps, FDA, GxP
1mo
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WAREHOUSE COORDINATOR
Amarillo, Texas, United States
OnsiteFull Time
1+ YOE1+ year warehouse experience (food manufacturing preferred); forklift certification required; knowledge of food safety standards (HACCP, GMP, FDA); familiar with inventory software, WMS and Microsoft Office; able to lift up to 50 lbs and work around machinery.
Microsoft Office, Warehouse Management System (WMS), HACCP, GMP, FDA
1w
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Quality Assurance Specialist
Austin, Texas, United States
$27-$45/hr OnsiteFull Time
1+ YOEBachelor's degree preferred, exposure to regulated environments (GxP/ISO/FDA), working knowledge of FDA requirements, auditing experience preferred, proficiency with Google Docs/Drive/Gmail, strong communication; ability to travel between sites.
Google Docs, Google Drive, Gmail
1mo
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Regulatory Compliance Specialist - Transplant Center
Houston, Texas, United States
OnsiteFull Time
2+ YOEBachelor's degree, 2 years clinical research or regulatory compliance experience in academic/FDA-regulated settings; knowledge of IRB/FDA/GCP, strong communication, data entry, and process improvement skills; Excel/Word/PowerPoint proficiency.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint
4w
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QA Technician (AUSTIN, TX, US, 78727)
Austin, Texas, United States
$54k/yr OnsiteFull Time
1+ YOEReview DHRs for FDA (21 CFR 820) and ISO 13485 compliance; H.S. diploma required (Associate's preferred); 1+ year in FDA-regulated manufacturing; audit and quality certification preferred; Microsoft Windows/Office and Oracle familiarity.
Microsoft Windows, Microsoft Office, Oracle
1w
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Director, Clinical Research Regulatory Affairs in United States, Texas, Houston, Houston (TX Med Ctr)
Houston, Texas, United States
$147k-$220k/yr RemoteFull Time
8+ YOE2+ MgmtBachelor's required, Master's preferred; 8+ years regulatory affairs experience with FDA submissions and oncology research; 2+ years lead project management; IND/IDE experience preferred; RAC preferred; strong FDA, ICH/GCP knowledge.
1w
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Director, Clinical Research Regulatory Affairs
Houston, Texas, United States
$147k-$220k/yr RemoteFull Time
8+ YOE2+ MgmtBachelor's degree required (Master's preferred);8+ years regulatory affairs experience with FDA submissions and oncology research,2+ years lead project management;IND/IDE and EMA exposure preferred;RAC preferred;knowledge of FDA, ICH, GCP.
3mo
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Part-Time Registered Nurse
Arlington, Texas, United States
$38-$42/hr OnsitePart Time
Licensed Texas RN with current licensure; knowledge of OSHA, FDA, and HIPAA compliance; part-time availability.
Electronic Medical Records, HIPAA Compliance
2mo
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Clinical Research Chart QA/Auditor
The Woodlands, Texas, United States
$60-$100/hr OnsiteContract
5+ YOE5+ years QA auditing in clinical research; FDA inspections; ICH-GCP; strong documentation and communication.
FDA inspections, ICH-GCP, 21 CFR Part 11, CAPAs, Audit reporting
3mo
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Part time Registered Nurse
Arlington, Texas, United States
$38-$42/hr OnsitePart Time
Part-time RN licensed in Texas; knowledge of OSHA, FDA, HIPAA; passionate about serving youth and families.
3mo
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Regulatory Compliance Officer
Carrollton, Texas, United States
OnsiteFull Time
5+ YOECoordinate regulatory submissions, internal audits; FDA liaison; 5+ years in quality/regulatory in manufacturing; travel globally.
Microsoft Office, Internet
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