3d
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FDA Laboratory Technician full time
Denver, Colorado, United States
OnsiteFull Time
Supports media and glassware preparation, autoclaving and MPW handling per USP/EPA/OSHA/FDA; ability to prepare media and bulk solutions; favorable Tier 2/Public Trust background investigation required.
2mo
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Research Services Clinical Sciences Senior Professional (Onsite)
Aurora, Colorado, United States
$59k-$75k/yr OnsiteFull Time
2+ YOESenior clinical research professional with leadership across studies, regulatory expertise (GCP/IRB/FDA), data management, and study operations.
REDCap, Excel, Regulatory Submissions
2mo
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Project Engineer 3
Marlborough or Louisville
$98k-$153k/yr OnsiteFull Time
3+ YOEBachelor’s degree in Engineering; 3+ years project management; regulated medical device experience preferred; FDA/ISO knowledge; PMP preferred.
PMO tools, Gantt charts, risk registers, design history file (DHF) documentation
3w
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Paramedic/EMT-P
Aurora, Colorado, United States
$28-$39/hr OnsiteFull Time
2+ YOEState EMT-Paramedic license, CPR and AED certification, basic IV therapy, FDA training completion, and 2 years clinical or hospital experience.
21h
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Senior Quality Control Specialist
Boulder, Colorado, United States
$128k-$155k/yr OnsiteFull Time
4+ YOE4+ years QC experience in biotech/pharma (GMP) with ability to perform analytical methods, interpret stability data, and follow FDA/ICH cGMP requirements.
IP-RP-UPLC, SAX-HPLC, GC, Mass Spec, FTIR, UV
1w
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Prin Regulatory Affairs Spec
North Haven or Mansfield or Mounds View or Boston or Lafayette
$120k-$180k/yr OnsiteFull Time
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.
2w
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Key Account Principal Clinical Specialist
Denver or United States
$87k-$173k/yr RemoteFull Time
3+ YOEAdvanced degree required, 3+ years EP industry experience, proficiency in Salesforce and PowerBI, willingness to travel ~50%, knowledge of FDA regulations, strong organization and multitasking skills.
Salesforce, PowerBI
1w
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Clinical Operations Manager II
Aurora, Colorado, United States
$72k-$88k/yr RemoteFull Time
4+ YOE2+ Mgmt4 years clinical research experience with 2 years project/operations management, knowledge of GCP/FDA/ICH, proficiency in Microsoft Office, strong communication and organizational skills.
Microsoft Outlook, Microsoft Word, Microsoft Excel
3w
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Product Packaging Team Member, Bakehouse
Aurora, Colorado, United States
$19-$31/hr OnsiteFull Time
Pack products to specification, follow USDA/FDA/OSHA and facility food-safety procedures, operate packaging equipment, accurately label and document product, and lift up to 50 lbs.
box maker, shrink tunnel, metal detector, forklift, pallet jacks, hand trucks, six-wheel carts, baler
1mo
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First Cook
Denver, Colorado, United States
$23/hr OnsiteFull Time
2+ YOE2 years experience; knowledge of mother sauces and multiple cooking methods; ability to follow recipes, comply with FDA/HACCP, communicate effectively, work under pressure, and be flexible on schedule.
1w
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Plant Manager
Denver or Clinton Township
OnsiteFull Time
10+ YOE10+ years leadership in injection molding or advanced manufacturing, expertise in scientific molding, Lean/Six Sigma, regulated environments (ISO 13485/FDA/ITAR), automation and financial management.
RJG, Lean Manufacturing, Six Sigma
3mo
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FSQA Manager
Denver, Colorado, United States
$86k-$142k/yr OnsiteFull Time
5+ YOE1+ Mgmt5+ years in food manufacturing/FSQA; Bachelor's in Food Science, Microbiology, Engineering, or related field; strong FDA/USDA, FSMA, HACCP knowledge; proven problem-solving and leadership.
1mo
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Research Nurse
Denver, Colorado, United States
$83k-$100k/yr OnsiteFull Time
1+ YOEActive RN license, knowledge of clinical research processes, FDA CFR and GCP, 1+ year oncology experience preferred, research experience and research certification (ACRP/CCRP) preferred.
3w
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Staff Software Engineer, Valence
Louisville, Colorado, United States
$130k-$145k/yr OnsiteFull Time
8+ YOE8+ years in surgical navigation or medical device software; proficiency in C++ on Linux, 3D geometry and imaging, image processing toolkits, experience in FDA-regulated environments, strong leadership and communication.
C++, Linux, Qt, DICOM, VTK, ITK, OpenCV, GIT, Azure DevOps
1mo
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QA Product Specialist
Boulder, Colorado, United States
$100k-$118k/yr OnsiteFull Time
5+ YOEBachelor's in science and 5 years pharmaceutical QA experience (or equivalent), strong cGMP/cGLP/FDA knowledge, validation and CAPA experience, audit support, technical review and quality leadership skills.
2w
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Learning Support Specialist - Oncology
Denver, Colorado, United States
$70k-$80k/yr OnsiteFull Time
5+ YOE5+ years clinical research experience (3+ years in oncology), training/mentoring experience, knowledge of GCP/ICH/FDA, competency with clinical systems, ability to travel and drive, lifting ability.
Electronic Medical Records (EMRs), eDocs, CTMS, Microsoft Office 365, Learning Management System (LMS)
2w
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Key Account Principal Clinical Specialist
Denver, Colorado, United States
$87k-$173k/yr RemoteFull Time
3+ YOEAdvanced degree, 3+ years EP industry experience, proficiency with Salesforce and Power BI, willing to travel ~50%, strong organization and clinical/sales collaboration skills, FDA/regulatory compliance.
Salesforce, Microsoft Power BI
2w
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Specialty Cook
Denver, Colorado, United States
$26/hr OnsiteFull Time
4+ YOE4 years experience preparing complex international recipes, ability to follow exact recipes and plating specs, knowledge of FDA/HACCP standards, strong communication and ability to work under pressure.
5d
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Validation Engineer
Frederick or Boulder
$82k-$129k/yr OnsiteFull Time
1+ YOEBachelor's in engineering or life sciences,1+ years relevant experience,knowledge of cGMP/FDA/ICH regulations,validation experience (IQ/OQ/PQ/SAT),CAPA and change control experience.
URS, Software Acceptance Testing (SAT), IQ, OQ, PQ, GAMP, 21 CFR, ICH, Eudralex Volume 4 Annex 15, CAPA, spreadsheets
2d
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Laboratory Quality and Compliance Manager
Denver, Colorado, United States
$86k-$134k/yr OnsiteFull Time
4+ YOEBachelor's degree and 4+ years laboratory experience required; MLS ASCP required. Knowledge of regulatory standards (Joint Commission, AABB, FDA, CMS, CLIA), inspections, policy writing, and quality improvement.