AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
2+ YOEAssociates degree or equivalent, 2+ years in a regulated environment or investigations, CAPA/investigation and project management skills, attention to detail, strong written and oral communication; FDA QSR/ISO13485 knowledge preferred.
Voltage Energy: Provider of electrical balance of system solutions for solar.
3+ YOE3+ years quality engineering experience in manufacturing; familiarity with ISO 9001/14001, PPAP, FMEA, SPC, MSA, CAPA; ability to read drawings/GD&T; bachelor's in engineering or related field or equivalent experience; Microsoft Office and ERP (SAP) proficiency.
Senior Technical Specialist, Engineering and Facilities
Durham, North Carolina, United States
$140k-$185k/yrOnsiteFull Time
Beam TherapeuticsNASDAQ: BEAM: Develops precision genetic medicines using base editing technology.
12+ YOE12+ years biotech/GMP engineering experience with technical writing, lifecycle documentation, CAPA/ECC management, validation knowledge, and strong cross-functional communication.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Smartsheets, Veeva QDocs, Veeva QMS, Kneat, DeltaV (PCS), Disego (BAS), OSI PI, BlueMountain RAM / CMMS
Duke Health: Provides comprehensive medical care, clinical research, and health education.
6+ YOEBachelor's in biological science, 6+ years QA/QC experience related to clinical trials; experience with GMP, audits, SOPs, investigations, CAPA, and FDA/FACT inspections preferred.
Research Triangle Park, North Carolina, United States
OnsiteFull Time
FujifilmTokyo Stock Exchange: 4901: Provider of diagnostic imaging and healthcare technology solutions.
3+ YOERequires a degree or equivalent experience, cGDP/cGMP knowledge, investigation and CAPA expertise, root cause analysis, technical writing, data analysis, and cross-functional team leadership.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint
Camco Manufacturing: Manufactures and provides accessories for RVs, boating, and camping.
Support incoming quality control and supplier inspections, maintain quality documentation and D365 records, perform audits, CAPA/NMR coordination, and assist continuous improvement; associate degree preferred.
Microsoft Dynamics 365 (D365), Microsoft Excel, Microsoft Word, Microsoft Outlook
Associate Director, Quality Assurance (Clinical Research Preferred)
Durham or Indianapolis or Wayne
$89k-$247k/yrRemoteFull Time
IQVIANYSE: IQV: Provides clinical research and healthcare data analytics services.
10+ YOE10+ years QA experience in pharmaceutical/biotech/CRO/clinical research, strong GxP/GCP knowledge, audit and CAPA experience, leadership, risk assessment, and Microsoft Office proficiency.
KBI Biopharma: Contract development and manufacturing for biopharmaceutical companies.
4+ YOEBachelor’s degree with 4 years (or HS with 10 years) in cGMP manufacturing; knowledge of bioprocessing equipment, quality systems, SOPs, CAPA, ERP/EDMS; strong communication and problem-solving skills.
1+ YOEHigh school diploma, minimum 1 year QA/warehouse/operations experience preferred; inspection, audit, root-cause analysis, CAPA, Microsoft Excel and business system proficiency required.
Monday.com, NetSuite, IntelliTrack, JotForm, Smartsheet, Microsoft Excel, Microsoft Office Suite
Lotus BakeriesEuronext Brussels: LOTB: Global manufacturer of Biscoff biscuits and natural snack brands.
0+ YOESupport QMS and lead daily quality assurance on the production floor; perform testing, inspections, audits, RCA and CAPA support; knowledge of HACCP, GMP, FSMA/FDA, SQF/BRC preferred.
HitachiTokyo Stock Exchange: 6501: Global provider of digital systems and social infrastructure solutions.
Bachelor's degree or 3+ years quality systems experience; working knowledge of ISO 9001:2015, audits, CAPA, document control, PFMEA/Control Plan support, and quality data analysis in manufacturing.
LCI: Creates jobs for the blind through manufacturing and retail.
10+ YOE10+ years QA/QC management in manufacturing, strong ISO 9001/13485 expertise, RCA/FMEA/SPC experience, audit and CAPA leadership, excellent communication and analytical skills (bachelor's preferred).
ISO 9001, ISO 13485, Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPS)
Senior Specialist, Manufacturing Technical Support
Durham, North Carolina, United States
$109k-$202k/yrOnsiteFull Time
NovartisNew York Stock Exchange: NVS: Develops and manufactures innovative prescription medicines for patients.
7+ YOEBachelor's in Engineering or Life Sciences,7+ years in biopharmaceutical GMP manufacturing,knowledge of FDA/GMP,QbD and Six Sigma,experience with deviations,CAPA and technical documentation,ability to travel up to 20%.
Atlantic Braids: Manufacturer of high-quality synthetic rope and cordage products.
5+ YOE2+ Mgmt5+ years QA/QC experience in manufacturing, 2+ years supervisory experience, bachelor’s degree preferred, experience with ISO 9001, audits, root-cause analysis, CAPA, ERP and Microsoft Office.
ERP, quality management software, Microsoft Office
AskBio: Develops gene therapies for neuromuscular and metabolic diseases.
2+ YOEBachelor's degree and 2+ years in a regulated GMP pharma/biotech lab; experience authoring GMP quality events (deviations, CAPAs, change controls); strong technical writing, multitasking, and communication skills.
LabVantage LIMS, Computer Maintenance Management System (CMMS)
OXBLondon Stock Exchange: OXB: Provides viral vector development and manufacturing services for therapies.
5+ YOEBachelor's in Life Sciences,5+ years pharma/biopharma experience (>=3 years in QC),experience with change controls/deviations/CAPAs and cGMP,ability to oversee raw material management and support audits.
Aurobindo PharmaNational Stock Exchange of India: AUROPHARMA: Manufactures and distributes generic and specialty pharmaceutical medications.
3+ YOE3–8 years QC experience in pharma with 2–3 years investigating OOS/OOT; strong technical writing, cGMP knowledge, CAPA and root-cause experience, and ability to review analytical data.