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2 дня назад

Deviation Investigation Support (Quality Control)

Формат работы
remote (только USA)/hybrid
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
Deviation Investigation Support (Quality Control): Supporting deviation investigations for pharmaceutical, biotech, and medical device programs through root cause analysis, CAPA creation, and deviation record approval with an accent on technical writing, laboratory quality systems, and cross-functional collaboration. Focus on investigating process events, setting up deviation review boards, routing records for approval, and completing effectiveness checks using LabVantage and related quality systems.

Location: United States; remote work is supported, with hybrid work encouraged for hires within a reasonable commute of a hirify.global office.

Company

hirify.global provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

  • Participate in meetings with site representatives regarding deviation events.
  • Collaborate with subject matter experts and provide investigation support and progress updates.
  • Conduct thorough root cause investigations, including process background and event overviews.
  • Create CAPAs and effectiveness checks for deviation records.
  • Set up deviation review boards when applicable.
  • Own deviation records through review, approval, and timely completion.

Requirements

  • Background in Quality Control Laboratories.
  • Experience with root cause investigations and CAPA creation.
  • Hands-on experience with LabVantage is required.
  • Excellent communication and technical writing skills.
  • Strong time management skills and ability to deliver timely, high-quality deviation records.
  • Ability to complete training, participate actively in meetings, and communicate progress clearly.

Nice to have

  • Experience with Veeva QMS, MODA, or SmartLab.

Culture & Benefits

  • 15-month full-time contract running from Q4 2026 through the end of Q4 2027.
  • Company-provided training for deviation investigation support.
  • Remote work support with hybrid collaboration encouraged where practical.
  • Inclusive workplace focused on diversity, equity, and inclusion.

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