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6 дней назад

Senior Quality Specialist

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Quality Specialist (GMP Manufacturing): Supporting batch release, quality records, product quality evaluations, and quality systems processes across manufacturing operations with an accent on regulatory compliance, defect assessment, and audit readiness. Focus on analyzing quality trends, coordinating non-conforming material disposition, maintaining SAP master data, and driving continuous improvement in a GMP environment.

Location: US - Greenwood, SC

Company

hirify.global operates a global manufacturing environment focused on delivering products that meet customer and regulatory quality expectations.

What you will do

  • Review batch records, verify compliance, and perform product release activities.
  • Manage quality records, batch documentation, retained samples, and archival processes.
  • Evaluate physical, manufacturing, and printing defects through inspections and testing.
  • Analyze quality trends, support investigations, and drive continuous improvement to improve product quality and manufacturing yield.
  • Coordinate segregation, documentation, and disposition of non-conforming and out-of-specification materials.
  • Support customer, health authority, and internal audits while maintaining SAP master data and quality management system records.

Requirements

  • Bachelor's degree in Business, Engineering, Science, or another technical discipline.
  • 5–10 years of experience in Quality Assurance, Quality Operations, or a related quality function.
  • Strong knowledge of quality systems, batch record review, product release, and quality documentation.
  • Experience with SAP and/or Manufacturing Execution Systems (MES).
  • Experience using quality data analysis and trending tools for problem-solving and continuous improvement.
  • Strong communication skills and the ability to work independently in a fast-paced manufacturing environment.

Culture & Benefits

  • Cross-functional collaboration with Operations, Engineering, Supply Chain, and Commercial teams.
  • Direct contribution to product quality, regulatory compliance, and operational excellence.
  • Equal employment opportunities for qualified applicants from all backgrounds.

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