62 fda jobs at 28 companies in Winchester, VA
1w
Save
Mark Applied
Hide
Senior Regulatory Affairs Scientist
Fort Detrick, Maryland, United States
OnsiteFull Time
12+ YOEMaster's degree and RAC required; 12+ years FDA regulatory affairs experience including INDs, NDAs, BLAs, IDEs, 510(k); experience leading FDA interactions and mentoring staff.
6d
Save
Mark Applied
Hide
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
2w
Save
Mark Applied
Hide
Clinical Research Coordinator (52088)
Bethesda or Herndon
$90k-$140k/yr OnsiteFull Time
Bachelor's in a related field, experience with EMR/CTMS/EDC, oncology clinical trial experience, knowledge of FDA/ICH-GCP, strong organizational and communication skills.
Electronic Medical Records (EMR), clinical trial management systems, electronic data capture platforms
1mo
Save
Mark Applied
Hide
Senior Business Analyst
Frederick, Maryland, United States
$83k-$125k/yr OnsiteFull Time
5+ YOE5-8 years clinical laboratory or informatics experience; bachelor’s or master’s in related field; expertise in UAT, system validation (GxP/CLIA/CAP/FDA), documentation, and laboratory systems.
LIS, LIMS, Epic Beaker, SCC Soft, Sunquest, Cerner Millennium, HL7, eDMS
2d
Save
Mark Applied
Hide
Laboratory Technician
Frederick, Maryland, United States
OnsiteFull Time
3+ YOEPerform tissue grossing, processing, embedding, microtomy, H&E and special staining, QC, follow SOPs and FDA/GLP regulations; detail-oriented, communicative, able to meet deadlines.
microtomy, H&E staining
2w
Save
Mark Applied
Hide
Operator II - 2nd Shift
Frederick, Maryland, United States
$17-$25/hr OnsiteFull Time
High school diploma or equivalent, ability to lift 40 lbs, follow GMP/ISO/FDA standards, operate manual and automated filling equipment, adhere to PPE and safety procedures.
1d
Save
Mark Applied
Hide
Quality Systems Associate
Frederick, Maryland, United States
$22-$30/hr OnsiteFull Time
High school diploma or GED, basic cGMP and quality systems knowledge, computer proficiency, attention to detail, problem-solving skills, and ability to understand FDA regulations and follow SOPs.
SOP
1w
Save
Mark Applied
Hide
Operations Supervisor - Food Production
Dulles, Virginia, United States
$69k-$74k/yr OnsiteFull Time
1+ YOEBachelor's degree or equivalent, 1–3 years related experience, leadership and problem-solving skills, working knowledge of OSHA/GMP/FDA/USDA/EPA, and Microsoft Office proficiency.
Microsoft Office, Windows
1mo
Save
Mark Applied
Hide
Warehouse Data Coordinator
Front Royal, Virginia, United States
OnsiteFull Time
3+ YOEMinimum 3 years food-industry warehousing experience, knowledge of HACCP/FDA/SQF, proficiency with WMS/ERP systems and Microsoft Excel, strong problem-solving, communication, and organizational skills.
WMS, ERP, Microsoft Office, Microsoft Excel
2w
Save
Mark Applied
Hide
Environmental Health and Safety Manager
Manassas, Virginia, United States
OnsiteFull Time
5+ YOEBachelor's in related field,5-7 years industrial EHS experience,knowledge of OSHA/EPA/NFPA/FDA/GMP,ability to lead audits,investigations,training,and regulatory liaison work.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
3w
Save
Mark Applied
Hide
Sr. Development Engineer
Leesburg or Allendale
$100k-$110k/yr OnsiteFull Time
2+ YOEB.S. in Mechanical/Biomedical Engineering required (M.S. preferred), 2+ years product development experience (medical device preferred), CAD proficiency, knowledge of FDA design controls and ISO 14971/13485.
SolidWorks, Creo
1mo
Save
Mark Applied
Hide
Specialty Cook
Dulles, Virginia, United States
$21/hr FieldFull Time
2+ YOE2+ years in a commercial high-volume kitchen, willingness to travel to support multiple airline kitchens, HS diploma, knowledge of FDA/HACCP food safety, ability to lift/stand, and English fluency.
1mo
Save
Mark Applied
Hide
Senior Business Analyst
Frederick, Maryland, United States
$83k-$125k/yr OnsiteFull Time
5+ YOE5+ years clinical laboratory or informatics experience; Bachelor’s or Master’s in relevant field; expertise in UAT, system validation (GxP/CLIA/CAP/FDA), authoring validation/regulatory documentation, and stakeholder engagement.
LIS, LIMS, middleware, instrument interfaces, Epic Beaker, SCC Soft, Sunquest, Cerner Millennium, HL7, eDMS
1mo
Save
Mark Applied
Hide
Manager, Facility Operations
Manassas, Virginia, United States
$85k-$135k/yr OnsiteFull Time
5+ YOE3+ Mgmt5+ years facilities management, 3+ years refrigeration experience, proven leadership of maintenance teams, regulatory compliance knowledge (OSHA, EPA, USDA, FDA), CMMS proficiency, project and budget management skills.
CMMS, BMS, warehouse control systems, Process Safety Management (PSM) tracking tool
2d
Save
Mark Applied
Hide
Procurement Manager
Germantown, Maryland, United States
$90k-$120k/yr OnsiteFull Time
5+ YOE5+ years procurement/inventory experience in pharma/biotech, strong negotiation and supplier risk management, ERP proficiency, knowledge of FDA/EU GMP/ICH Q7, bachelor's degree or equivalent experience preferred.
NetSuite, SAP, MS-Word, MS-Excel
2d
Save
Mark Applied
Hide
Principal Regulatory Scientist
Reston, Virginia, United States
$116k-$181k/yr OnsiteFull Time
4+ YOEDoctorate in a relevant scientific discipline with ≥4 years experience (or master’s with ≥6 years); demonstrated FDA regulatory experience; strong writing, communication, analytical skills; US citizenship and active secret clearance required.
3w
Save
Mark Applied
Hide
Vice President, Quality - Pharma & Diagnostics
Chantilly or Clifton or San Juan Capistrano or Secaucus
$300k-$350k/yr HybridFull Time
15+ YOE10+ Mgmt15+ years leadership in regulated healthcare/pharma/device quality; expert knowledge of FDA QMSR and ISO 13485; 10+ years managing multi-site quality teams; Bachelor’s required, advanced degree preferred.
2w
Save
Mark Applied
Hide
Food Safety & GMP Quality Assurance Consultant Part time (Remote)
Frederick or North Carolina or Maryland
$63-$77/hr RemotePart Time
15+ YOEBachelor's in a relevant science,15+ years QA/food safety experience,knowledge of FDA/FSMA/21 CFR/HACCP/GMP,GFSI auditing experience,PCQI/HACCP or Lead Auditor preferred,travel availability.
1mo
Save
Mark Applied
Hide
Manager, Facility Operations
Manassas, Virginia, United States
$65k-$130k/yr OnsiteFull Time
5+ YOE3+ Mgmt5+ years facilities management, 3+ years refrigeration experience, leadership of maintenance teams, CMMS proficiency, strong knowledge of OSHA/EPA/USDA/FDA/GMP, project and budget management, valid driver’s license.
Computerized Maintenance Management Systems (CMMS), Computerized Building Management Systems (BMS), warehouse control systems, PSM tracking tool
1w
Save
Mark Applied
Hide
Pharmacist
Leesburg, Virginia, United States
$65-$68/hr OnsitePart Time
1+ YOEBachelor's in Pharmacy (PharmD preferred), current state pharmacist license, 1 year long-term care experience desired, EMR and pharmacy system proficiency, knowledge of CMS/DEA/FDA, strong clinical judgment and communication.
Electronic Medical Records (EMR), pharmacy information systems