73 quality specialist jobs at 36 companies in Moncure, NC
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Sr Quality Specialist
Raleigh, North Carolina, United States
OnsiteFull Time
Par Health: Manufacturing essential generic medicines and active pharmaceutical ingredients.
5+ YOEBachelor's degree preferred, 5+ years in quality assurance or pharmaceutical manufacturing, and proficiency with Microsoft Word, Excel, and Adobe. Requires GMP and regulatory knowledge plus project and communication skills.
ABBSIX Swiss Exchange: ABBN: Provides electrification and automation technologies for global industries.
10+ YOERequires a bachelor's degree in engineering or equivalent experience, 10+ years of quality management experience, ISO 9001:2015 lead auditor certification, manufacturing expertise, and willingness to travel 25%.
Alcami: Contract development and manufacturing organization for pharmaceutical companies.
5+ YOEBachelor's degree in chemistry, biology, or related field with 13+ years of GMP experience, or related master's degree; requires aseptic manufacturing, GMP, Annex 1, regulatory, communication, and mentoring expertise.
FujifilmTokyo Stock Exchange: 4901: Provider of diagnostic imaging and healthcare technology solutions.
0+ YOEBachelor’s in Life Sciences/Engineering with 2 years experience OR Master’s with no experience; 1-3 years GMP experience; validation and quality oversight in FDA-regulated facilities; knowledge of GAMP5, data integrity, and 21 CFR requirements.
ASTM E2500, Smartsheets, Trackwise, Veeva, Kneat, GAMP5, 21 CFR Part 820, 21 CFR Part 11
Research Triangle Park, North Carolina, United States
OnsiteFull Time
Fujifilm SonositeTokyo Stock Exchange: 4901: Develops portable ultrasound systems for point-of-care medical diagnostics.
3+ YOEReview batch records, audit trails, and area inspections for cGMP drug substance manufacturing; document findings and support incident resolution. Requires relevant industry experience per degree level and fluency in English.
8+ YOEBS in life science and 8+ years in regulated quality operations; experience with supplier/distributor qualification, audits, CAPA, change control, risk assessment, and quality systems.
Kyowa KirinTokyo Stock Exchange: 4151: Researches and manufactures pharmaceutical therapies for rare and intractable diseases.
5+ YOEBachelor's in life or pharmaceutical sciences, 5+ years GxP quality engineering experience, inspection/audit readiness, validation, change control, lifecycle and PM/CMMS experience, risk assessments (FMEA), and ALCOA+/21 CFR Part 11 familiarity.
5+ YOEBachelors in life sciences and 5+ years GMP quality experience; ability to review CMC batch records, perform deviation assessments, support CDMO oversight, and ensure compliance with 21 CFR and ICH guidance.
8+ YOEBachelor's degree in a scientific or technical discipline; 8–10 years in GxP and 4 years leading quality projects. Requires GxP, FDA, EMA, ICH, ISO, QRM, data integrity, and sterile manufacturing expertise.
HitachiTokyo Stock Exchange: 6501: Global provider of digital systems and social infrastructure solutions.
5+ YOEBachelor's in engineering, 5+ years quality/continuous improvement experience in manufacturing, ISO 9001 knowledge, Lean/Six Sigma/5S/VSM expertise, Minitab and Excel proficiency, bilingual English/French, authorized to work in the U.S., willingness to travel ~25%.
GuerbetEuronext Paris: GBT: Provides contrast media and medical devices for diagnostic imaging.
5+ YOEBachelor's degree and 5+ years QA experience in a GMP-regulated environment; strong GMP documentation, audit, change control, CAPA, and regulatory (FDA/EMA/ICH) knowledge.
State Employees' Credit Union: Banking and financial services for North Carolina state employees.
0+ YOEHigh school diploma or GED, 0–2 years relevant experience, MS Office proficiency, strong analytical, research, communication, organizational, and collaboration skills; fluent English required.
Microsoft Office Suite, Microsoft Excel, Microsoft Word, Microsoft Outlook, Microsoft PowerPoint
Adams Electric Company: Provides professional electrical contracting and construction services for commercial projects.
4+ YOEManage and perform QC tasks for electrical construction projects, inspect and test installations to NEC, prepare audit reports, support project teams, familiarity with MS Word/Excel, 4 years electrical construction experience preferred.
Specialist I, II, III Manufacturing Quality Systems
Holly Springs, North Carolina, United States
OnsiteFull Time
CSLASX: CSL: Global biotechnology producing plasma-derived and recombinant therapies.
1+ YOEBachelor's degree in science or engineering or equivalent experience; 1+ year in deviations, root cause analysis, CAPA, and change control; cGMP experience and strong troubleshooting skills.
Specialist I, II, III Manufacturing Quality Systems
Holly Springs, North Carolina, United States
OnsiteFull Time
CSLASX: CSL: Global biotechnology developing and manufacturing protein-based therapies and vaccines.
1+ YOEBachelor's degree in science or engineering, or equivalent industry experience, plus 1+ year in deviation management, root cause analysis, CAPA, and change control in a cGMP environment.
Alcami: Provides contract drug development and manufacturing services.
5+ YOEBachelor's in Chemistry/Biology with significant GMP experience (or Master's in related field). Minimum five years related experience; aseptic parenteral and Annex 1/GMP knowledge; visual inspector qualification and gowning experience.
Novo NordiskNYSE: NVO: Develops and manufactures medicines for diabetes and chronic diseases.
2+ YOEBachelor's degree in life sciences, chemistry, engineering, or related field and 2+ years of pharmaceutical instrument, laboratory validation, or engineering experience. GMP knowledge required; project management and validation protocol experience preferred.
UNC Health: Provides public healthcare and medical education in North Carolina.
3+ YOEBSN and active North Carolina RN license, 3 years clinical experience, medical record abstraction and quality improvement experience, knowledge of documentation/regulatory standards, and ability to educate providers.
The Steel Network: Manufactures light gauge cold-formed steel studs and connectors.
Perform incoming, in-process and pre-shipment inspections, document nonconformities, calibrate measurement devices, support root-cause investigations; high school diploma and experience with measuring devices and metal forming equipment.