2mo
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Senior, IT GXP Systems Specialist
El Segundo, California, United States
$55-$61/hr OnsiteFull Time
4+ YOE4+ years in IT systems administration; 1+ year in a GxP environment; bachelor's in IT/CS/engineering or 8+ years with HS.; knowledge of 21 CFR Part 11 and CSV.
Windows, TCP/IP, DNS, DHCP, VLANs, Active Directory, 21 CFR Part 11, GxP, CSV
2mo
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GxP Laboratory Systems Administrator
Madison or Verona
$90k-$115k/yr OnsiteFull Time
4+ YOE4+ years administering LIMS/CGS in a GxP environment; Bachelor's in computer science or life sciences; strong MS Office and data acquisition tools; ability to multitask and work under deadlines.
LIMS, Chromatography Data Systems, Spectrophotometry Systems, Openlab, Chemstation, Cary UV
2mo
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Sr Manager, GxP Compliance Officer
Lake Zurich or United States
$172k-$180k/yr RemoteFull Time
8+ YOEBachelor’s degree; 8+ years in pharma/GxP; US-FDA compliance expertise; strong QA/GxP knowledge; ability to travel; remote work eligibility.
2mo
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GxP & Lab Systems Administrator
Rockville, Maryland, United States
$77k-$95k/yr OnsiteFull Time
2+ YOEBA/BS in CS or science, 2+ years IT systems administration, Windows, LIMS/Empower, GxP systems, documentation, problem solving.
Windows, LIMS, Empower, MassLynx, CSV, SOPs
2mo
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GxP Facilities Specialist
Framingham, Massachusetts, United States
$90k-$96k/yr OnsiteFull Time
10+ YOE10+ years in process support equipment and plant utility maintenance; 10+ years in a cGMP environment; leadership experience; maintenance SOP development; CMMS/BMS proficiency; on-call coverage.
CMMS, BMS, Blue Mountain, Alberio
1w
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Sr Director, QA- GxP Systems
Needham, Massachusetts, United States
$258k-$280k/yr HybridFull Time
10+ YOEBachelor's in life sciences,10+ years biotech/pharma QA with GxP systems, vendor oversight, CSV, audits, and Part 11 compliance; experience with eQMS/EDMS and regulated clinical workflows.
eQMS, EDMS
2d
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GXP Technician I - Applied Gene & Cell Therapy Center (Operations, Controls & Support)
Cincinnati or Cincinnati
$22-$28/hr OnsiteFull Time
3+ YOEHigh school diploma, 3+ years related experience, GMP/GxP documentation, environmental monitoring, equipment maintenance, SOP compliance, and training completion.
3w
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Senior Manager GxP Training
Morristown or Norwich
$104k-$128k/yr OnsiteFull Time
5+ YOEBachelor's in Life Sciences/HR (Masters preferred), 5+ years training & development experience in pharmaceutical/healthcare, practical cGxP knowledge, LMS experience, strong communication, project management, and regulatory/audit experience.
Learning Management System (LMS)
2mo
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Associate Director, GxP Compliance and Auditing
Bridgewater, New Jersey, United States
HybridFull Time
12+ YOE5+ MgmtBachelor in science required; 12+ years GxP quality/compliance; 5+ years leadership; audit experience; cross-site; regulatory inspections.
GxP auditing tools, Quality Management System, Regulatory Intelligence tools
2mo
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Manager II, Enterprise Applications (R&D & GxP Systems)
Irvine, California, United States
$134k-$188k/yr HybridFull Time
8+ YOEBachelor’s degree and 8+ years in life sciences IT; 6+ years with GxP systems; knowledge of 21 CFR Part 11, EU Annex 11; Veeva Vault experience a plus.
Veeva Vault, QMS, GxP systems, SDLC, Validation, ERP/IT systems
3w
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Associate Director, GxP Operations Support Lab Systems
Boston, Massachusetts, United States
$162k-$242k/yr OnsiteFull Time
8+ YOESupports GxP documentation and electronic systems (SOPs, WIs, batch records), manages eQMS/CAPA/deviations/change control, implements/optimizes LIMS, MES, Tulip, oversees training, and supervises staff. Requires 8 years GMP experience.
eQMS, LIMS, MES, Tulip, Microsoft Office
1mo
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Senior Manager, GxP Electronic System Validation QA
Redwood City, California, United States
$164k-$205k/yr HybridFull Time
8+ YOEBachelor's degree or equivalent; minimum 8 years QA experience in pharma/biotech supporting GxP computerized systems; expertise in CSV/CSA, GAMP 5, SDLC, FDA 21 CFR Part 11, EU Annex 11, ALCOA+; audit and vendor qualification experience.
Computerized Systems Validation (CSV), Computer Software Assurance (CSA), GAMP 5, SDLC, FDA 21 CFR Part 11, EU Annex 11, ALCOA+
3w
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GxP Lab Computing Analyst ( second shift)
Cambridge, Massachusetts, United States
OnsiteFull Time
4+ YOEBachelor's/Master's in pharma/biotech/biomedical/chemical, 4+ years relevant experience (incl. 1 year software dev/testing and 1 year business analysis), lab IT troubleshooting, validation/compliance, customer liaison, and MS Office proficiency.
Unix, Windows, MVS, Object Oriented Programming, Structured Programming, Waterfall, Agile, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Visio, Microsoft Project, Microsoft SharePoint
3mo
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GxP Senior Training Specialist
Philadelphia, Pennsylvania, United States
OnsiteFull Time
3+ YOE3-5 years in GxP training or quality systems; LMS administration; eLearning/Instructional design; familiarity with FDA regulations; Bachelor's degree or equivalent experience.
Veeva, Microsoft Office, Word, Excel, Access, Outlook, Articulate Storyline, Adobe Captivate, Adobe Connect, Adobe Photoshop, Adobe Illustrator, Adobe After Effects, Adobe Premiere
18h
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IT Validation Lead (GxP / CSV)
San Diego, California, United States
$65-$80/hr OnsiteContract
5+ YOE5+ years CSV/IT Quality experience in GxP life sciences, strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, experience authoring validation documentation, data integrity and audit readiness, strong communication skills.
MES
1mo
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Manager/ Senior QA Associate, GxP Quality Systems
Carlsbad or Boston or Dublin
$71k-$102k/yr OnsiteFull Time
3+ YOEBachelor's degree in a science-related field, 3+ years quality assurance experience in pharmaceutical/biotech, strong knowledge of GxP/GMP and quality systems, familiarity with AI in GxP desirable, strong communication and problem-solving.
4w
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Sr. Quality Specialist, GxP Document Control
Boston, Massachusetts, United States
$105k-$128k/yr HybridFull Time
5+ YOEBachelor's in a scientific discipline (or equivalent), 5+ years QA/document control experience in regulated biotech/pharma, GxP/eQMS knowledge, audit/CAPA/training support, Smartsheet and Microsoft Excel proficiency.
electronic Quality Management Systems (eQMS), Smartsheet, Microsoft Excel
3mo
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GxP Maintenance Tech II- 2nd Shift
Boston, Massachusetts, United States
$37-$43/hr OnsiteFull Time
Hands-on experience with electrical, HVAC, mechanical, and plumbing systems; experience with BMS (Metasys) and CMMS (Nuvolo); basic GxP/GMP and OSHA knowledge; ability to lift up to 50 lb and participate in on-call rotation.
Nuvolo, Metasys, CMMS, P&IDs
2mo
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Manager II, Enterprise Applications (R&D & GxP Systems)
Irvine, California, United States
$134k-$188k/yr HybridFull Time
8+ YOE8+ years IT in life sciences/pharma; 6+ years GxP systems; Veeva Vault; SDLC and validation; 21 CFR Part 11; strong communication; vendor management.
Veeva Vault, RIM, CTMS, eTMF, JReview, Minitab, JMP
4w
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Adjunct Faculty - Regulatory & GxP Writing for Life Sciences
Boston or Worcester or Manchester
$3k-$4k/yr RemotePart Time
Bachelor's degree required; professional experience writing/reviewing GxP documentation in regulated life‑sciences environments; strong written/verbal communication and online teaching ability; Blackboard experience desired.
Blackboard
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