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
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
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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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
4w
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Associate Quality Engineer
Houston, Texas, United States
$51k-$101k/yr OnsiteFull Time
0+ YOEBachelor's in engineering or technical field (or equivalent), 0-2+ years engineering experience, knowledge of FDA/GMP/ISO 13485 & 14971, use of quality tools, Six Sigma/Lean experience preferred, strong communication and statistical/data analysis skills.
FDA, GMP, ISO 13485, ISO 14971, Six Sigma, Lean Manufacturing, QMS, EMS, CAPA
4w
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Associate Quality Engineer
Houston, Texas, United States
$51k-$101k/yr OnsiteFull Time
0+ YOEBachelor's in engineering or technical field (or equivalent), 0–2+ years engineering experience, knowledge of FDA/GMP/ISO standards, experience with quality tools, statistical/data analysis, Six Sigma/Lean experience preferred, strong communication and project skills.
FDA, GMP, ISO 13485, ISO 14971, Six Sigma, Lean Manufacturing, QMS, EMS
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
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.
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
1w
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Tooling Technician I
Rosenberg, Texas, United States
OnsiteFull Time
Inspect, clean, polish, measure, and maintain tablet and capsule tooling to meet FDA requirements using precision measuring tools.
Calipers, micrometer, Vernier caliper, feeler gauges, Dremel tool, bench buffer/grinder wheel, dial indicator, die bore gauge, go no-go gauges
2mo
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Plasma Center LPN
Houston, Texas, United States
$24-$33/hr OnsiteFull Time
2+ YOELPN/LVN license in state; CPR/AED; basic IV therapy; 2 years clinical/hospital; FDA training completion; support EHS.
1w
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Quality Assurance Specialist
Houston, Texas, United States
OnsiteFull Time
5+ YOEBachelors in science required. Experience with GMP, investigations, CAPA, audits, quality metrics, and MasterControl; 5+ years conducting investigations in FDA-regulated environments preferred.
MasterControl, eQMS
2mo
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Clinical Research Site Director
Boston or Houston
OnsiteFull Time
8+ YOE5+ Mgmt8+ years clinical research experience; 5+ years managing multiple trials and teams; strong knowledge of FDA regulations, ICH-GCP, and site operations.
EDC, IVRS, Electronic Data Capture, SOPs
2mo
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QA and Food Safety Manager (Missouri City, TX, US, 77489)
Missouri City, Texas, United States
$97k-$145k/yr OnsiteFull Time
5+ YOE5+ Mgmt5 years supervisory experience in food manufacturing; BA/BS in related field; knowledge of GMP, HACCP, FDA regulations; strong analytical and leadership skills.
Excel
3mo
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Plasma Center Manager (TX-Houston, US)
Houston, Texas, United States
OnsiteFull Time
3+ YOEBachelor’s degree; typically 3+ years related experience; supervisory experience; knowledge of cGMP, FDA, OSHA; plasma or blood product experience; leadership and budgeting skills.
cGMP, FDA_regulations, OSHA_compliance, quality_management_systems
2mo
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Senior Process Engineer
Stafford, Texas, United States
OnsiteFull Time
7+ YOE7+ years of process engineering in regulated manufacturing; medical device experience preferred; strong FDA QSR/ISO 13485 knowledge; root cause analysis experience.
1w
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CMA, LVN or RN - Kingwood
Kingwood, Texas, United States
OnsiteFull Time
1+ YOECMA certification or LVN or RN license valid in Texas, 1–2 years medical experience, knowledge of OSHA/FDA/HIPAA, skilled charting, and strong communication.
1w
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MANUFACTURING ENGINEER
Rosenberg, Texas, United States
$80k-$100k/yr OnsiteFull Time
5+ YOEBachelor's degree in engineering,5+ years engineering experience in pharmaceutical or regulated manufacturing,cGMP and FDA knowledge,equipment qualification and process validation experience,SAP experience.
SAP
3mo
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Sr. FSQ Technician - 2nd Shift Pasadena
Pasadena, Texas, United States
$21-$23/hr OnsiteFull Time
2+ YOEHigh school diploma or GED; 2+ years food safety/QA experience; SAP and InfinityQS; HACCP knowledge; USDA/FDA familiarity; ability to investigate incidents.
SAP, InfinityQS, IQS