65 capa jobs at 40 companies in Hyattsville, MD
1w
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Process Engineer
Rockville, Maryland, United States
$90k-$120k/yr OnsiteFull Time
Requires a bachelor's degree in engineering or equivalent, biopharmaceutical manufacturing experience, process equipment knowledge, capital project management, and familiarity with cGMP, validation, change control, investigations, and CAPA.
FAT, SAT, CAPA
4d
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Senior Specialist, Cell Therapy Vein-to-Vein Operations
Gaithersburg or Tarzana
$89k-$134k/yr OnsiteFull Time
5+ YOEBachelor's degree or equivalent experience; 5+ years in a GxP-regulated environment; experience with quality systems, deviations, CAPAs, change controls, controlled documents, risk assessments, SOPs, and quality metrics.
GxP, CAPA, SOP
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Quality Specialist 3 - Compliance and Audits
Rockville, Maryland, United States
$71k-$106k/yr OnsiteFull Time
2+ YOEBachelor's degree in life science and 2+ years in quality assurance audits, root cause analysis, and CAPA. Requires GMP/GLP knowledge, analytical, communication, organizational, and problem-solving skills.
HACCP, FMEA, CAPA, Quality Management System (QMS), FDA 21 CFR Parts 58, 210, 211, Part 11, EU GMP, ICH Q9/Q10
4d
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Senior Specialist, Cell Therapy Vein-to-Vein Operations
Gaithersburg or Tarzana
$89k-$134k/yr OnsiteFull Time
5+ YOEBachelor's degree or equivalent relevant experience; 5+ years in a GxP-regulated environment; experience with deviations, CAPAs, change controls, quality risk assessments, controlled documents, SOPs, and quality metrics.
CAPA, SOPs
4d
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Senior Specialist, Cell Therapy Vein-to-Vein Operations
Gaithersburg or Tarzana
$89k-$134k/yr OnsiteFull Time
5+ YOEBachelor’s degree or equivalent relevant experience; 5+ years in a GxP-regulated environment; quality systems, deviations, CAPAs, change controls, controlled documents, risk assessments, SOPs, and quality metrics experience.
GxP, SOPs, CAPAs
1w
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Operations Safety Lead
Sunnyvale or Washington, D.C. or San Diego or Fort Walton Beach or Ann Arbor or London or Stuttgart or Munich or Stockholm or Bengaluru or Seoul or Tokyo
$150k-$200k/yr OnsiteFull Time
7+ YOE7+ years in operational compliance, transportation safety, program management, or related work, including 3+ years in a safety-critical or regulated environment; experience owning compliance frameworks, RCA, CAPA, and audit-ready records.
ISO 26262, SOTIF, UL 4600, DOT, FMCSA, OSHA, MSHA, CAPA, RCA
5d
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Fleet Reliability Engineer
Arlington, Virginia, United States
OnsiteFull Time
5+ YOEBachelor's degree or equivalent experience; 5+ years engineering deployed electromechanical hardware, including 2+ years in reliability or field engineering. Requires RCA, FMEA, CAPA, SQL, Python, travel, and US work authorization.
SQL, Python, 8D, 5-Whys, FMEA, fault-tree analysis, CAPA, RMA, OTA, SATCOM, IEC 60529, MIL-STD-810, IEC 60068
2mo
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MANAGER PERIANESTHESIA
Prince Frederick, Maryland, United States
$36-$52/hr OnsiteFull Time
3+ MgmtLead PACU, PAT, SDS; 3-5 years perianesthesia; 2-3 years supervisory experience; RN licensure; BSN required; MSN/MHA/MBA preferred; CPR/ACLS; CPAN/CAPA; ASPAN membership.
RN License, CPR, ACLS, CPAN, CAPA, ASPAN
2mo
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Senior Engineer, Supplier Quality Assurance - Batteries
Houston or Arlington
HybridFull Time
5+ YOEBachelor's in engineering, 5+ years supplier quality/quality engineering in electrical/power electronics/energy storage, experience with batteries/BESS, APQP/PPAP/FMEA/MSA/SPC/8D/CAPA, VDA/IATF experience preferred, travel up to 40%.
VDA 6.3, ISO 9001, IATF 16949, APQP, PPAP, DFMEA, PFMEA, Control Plans, MSA, SPC, 8D, CAPA, FAI, Salesforce, UL 9540A, IEEE 1547, UL, IEC, CE, IEEE, NFPA, REACH, RoHS, Lean, Six Sigma, Kaizen, ISO 14001
2mo
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Manager, Manufacturing, Fill Finish (Drug Product)
Baltimore, Maryland, United States
$145k-$165k/yr OnsiteFull Time
5+ YOE2+ MgmtMS (5+ yrs) or BS (8+ yrs) in scientific/engineering/pharmaceutical/biotech field, 5+ yrs GMP sterile fill-finish experience, 2+ yrs people management, familiarity with EMS/CMMS/CAPA, strong analytical and aseptic manufacturing knowledge.
EMS, CAPA, CMMS
3mo
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QC Manager
Germantown, Maryland, United States
$85k-$115k/yr OnsiteFull Time
7+ YOE2+ MgmtOversee QC team; ensure cGMP lab compliance; develop SOPs, CAPAs, and deviations; supervise QA activities.
qPCR, HPLC, ELISA, Cell-based Assays
2w
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Quality Assurance Manager
Manassas, Virginia, United States
OnsiteFull Time
6+ YOEcGMP and FDA knowledge, 6+ years QA experience in pharmaceutical manufacturing (or master's with 4+ years), strong documentation, audit, CAPA, and training skills.
Microsoft Office Suite, Adobe
1mo
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Policy Analyst (Human Subjects Research/Protection) (Part-Time) (51996)
Research Triangle Park or Herndon
$10k-$155k/yr OnsitePart Time
20+ YOEPh.D. in biological/social/biomedical sciences, 20+ years experience, skilled in IRB processes and 45 CFR 46, auditing, CAPA, policy and manuscript writing, and delivering regulatory training.
1w
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Quality Specialist 3 - Compliance and Audits
Rockville, Maryland, United States
$71k-$106k/yr OnsiteFull Time
2+ YOEBachelor's degree in life science and 2+ years in quality assurance audits and root cause/CAPA work. Requires regulatory knowledge, analytical and communication skills, and independent stakeholder collaboration.
Quality Management System (QMS), HACCP, FMEA, FDA 21 CFR Parts 58, FDA 21 CFR Parts 210, FDA 21 CFR Parts 211, FDA 21 CFR Part 11, EU GMP, ICH Q9/Q10
1mo
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Principal Quality Systems Specialist
Northridge or California or Seattle or Washington or Boston or New York City or Los Angeles County or United States
$121k-$205k/yr OnsiteFull Time
5+ YOEBaccalaureate degree with 7+ years (or advanced degree with 5+ years) in quality systems; experience with QMS, Change Management, CAPA, audits, and Microsoft Office; strong communication and prioritization skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Agile, Trackwise, Microsoft Teams, Microsoft Project, Power BI
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QA Team Lead
Frederick, Maryland, United States
$107k-$139k/yr OnsiteFull Time
3+ YOEGMP QA experience in drug substance/product manufacturing; degree in technical discipline or equivalent experience; knowledge of GMP, SOPs, investigations, deviations, CAPA; strong communication and leadership skills.
Microsoft Word, Microsoft Excel, PowerPoint
2d
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Organ Procurement Transplantation Network (OPTN) Subject Matter Expert
United States or Rockville
$140k-$190k/yr RemoteFull Time
General Dynamics Information TechnologyNYSE: GD: Provides mission-critical IT services to government and defense organizations.
20+ YOEBachelor's degree in healthcare administration, public health, or policy and 20+ years of experience; expertise in OPTN policies, organ allocation, federal oversight, RCA, CAPA, compliance, and transplant operations.
Artificial Intelligence (AI)
1w
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Quality Specialist 3 - Compliance and Audits
Rockville, Maryland, United States
$71k-$106k/yr OnsiteFull Time
2+ YOEBachelor's degree in life science and 2+ years in quality assurance audits, quality agreements, root cause analysis, and CAPA. Requires regulatory compliance, analytical, communication, and problem-solving skills.
HACCP, FMEA, Quality Management System (QMS), GMP, GLP, FDA 21 CFR Parts 58, 210, 211, Part 11, EU GMP, ICH Q9/Q10, SOP
1mo
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Corporate Food Safety Manager
Baltimore, Maryland, United States
$75k-$85k/yr OnsiteFull Time
Experience in food or beverage manufacturing with strong knowledge of HACCP, GMP/CGMP, ISO 9001, FDA regulations, quality audits, CAPA, Six Sigma and Lean; training and project management experience.
HACCP, GMP, CGMP, ISO 9001, FDA, Six Sigma, Lean, GD&T, GxP
2w
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Staff Mission Assurance Engineer - Design Quality
Linthicum or Rolling Meadows
$169k-$254k/yr OnsiteFull Time
8+ YOEAdvanced quality engineering experience with root-cause/CAPA, knowledge of ISO9001/AS9100, Six Sigma, ability to obtain U.S. Secret clearance, and 8+ years relevant experience (varies by degree).
PLM, SysML, Model-Based Systems Engineering (MBSE), digital twin