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7 дней назад

Manufacturing Specialist, Quality Assurance (Night Shift)

Формат работы
onsite
Тип работы
fulltime
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
Manufacturing Specialist, Quality Assurance (Night Shift) (Pharmaceutical Manufacturing): Supporting quality assurance activities in a site-based pharmaceutical manufacturing environment with an accent on production readiness, product status control, record review, and FDA compliance. Focus on investigating deviations, identifying root causes, implementing corrective actions, and escalating potential quality concerns during four 10-hour night shifts.

Location: Bend, Oregon, United States; fully site-based. Schedule: Sunday through Wednesday nights, 4:00 PM–3:00 AM, including a one-hour break. Occasional weekend work or on-call availability may be required. Relocation assistance is available for eligible candidates and their families.

Company

hirify.global is a global life sciences company operating more than 30 sites across five continents and manufacturing medicines and therapies.

What you will do

  • Perform area clearance activities to confirm production readiness and compliance.
  • Apply and maintain product status labels, including QA hold and rejected-material labels.
  • Review production records for accuracy and adherence to quality standards.
  • Support quality systems implementation and continuous improvement initiatives.
  • Monitor product compliance throughout the manufacturing process.
  • Assist with investigations, root cause analysis, corrective actions, and escalation of quality concerns.

Requirements

  • Experience in pharmaceutical, biotechnology, or a related industry.
  • Knowledge of quality assurance processes and FDA regulations.
  • Ability to work independently and adapt to changing priorities.
  • Strong attention to detail and clear written and verbal communication skills.
  • Ability to work regularly on site and use personal protective equipment when required.

Nice to have

  • Experience supporting investigations or deviation management.

Culture & Benefits

  • Inclusive, ethical, and collaborative working environment.
  • Medical, dental, and vision insurance.
  • Performance-based compensation programs.
  • Career growth and development opportunities.
  • Culture centered on collaboration, accountability, excellence, passion, and integrity.

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