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9 часов назад

MQA Specialist - 2nd Shift

60 966 - 85 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
junior
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
MQA Specialist - 2nd Shift (GMP Quality Assurance): Providing quality oversight for pharmaceutical production processes, laboratories, documentation, and finished-product storage with an accent on shop-floor compliance, deviation management, and aseptic manufacturing controls. Focus on investigating quality issues, proposing CAPAs, monitoring production activities, and ensuring adherence to FDA, GMP, and company procedures.

Location: Grand Island, New York, United States; on-site, 2:00 PM–10:30 PM Monday through Friday

Salary: $60,966–$85,000 per year

Company

hirify.global provides healthcare products and operates regulated pharmaceutical production facilities.

What you will do

  • Provide quality oversight across production, support processes, laboratories, warehousing, storage, facilities, and utilities.
  • Verify weighing and dispensing, component preparation, in-process controls, filling, lyophilization, finishing, packaging, and visual inspection activities.
  • Identify critical deviations, stop production when necessary, contain affected materials or products, and escalate systemic issues to site management.
  • Support investigations, root-cause analyses, corrective and preventive actions, validation studies, media fills, repackaging, and reworking.
  • Review master batch records and logbooks for GMP and procedural compliance and provide real-time shop-floor documentation support.
  • Drive continuous quality improvement and participate in 5S and other compliance projects.

Requirements

  • High school diploma and 1–3 years of relevant work experience.
  • Associate degree or experience in a GMP-regulated industry is preferred.
  • Knowledge of regulatory requirements, industry best practices, and production technologies.
  • Competence with computerized systems; Word, Access, and Excel knowledge is a plus.
  • Strong organization, troubleshooting, stress resilience, personal integrity, and relevant production experience.

Culture & Benefits

  • Continuous quality improvement culture with an active shop-floor presence.
  • Medical, prescription drug, dental, and vision coverage.
  • 401(k) plan with company contributions, life insurance, disability coverage, and wellness benefits.
  • Paid vacation, holidays, personal days, and an employee assistance program.
  • Employment is at-will and subject to applicable federal and state laws.

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