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2 дня назад

Senior Specialist, Lead Investigator (Pharmaceutical Manufacturing)

80 000 - 117 500$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior/lead
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR
Senior Specialist, Lead Investigator (Pharmaceutical Manufacturing): Leading investigations and root cause analysis for manufacturing issues and deviations with an accent on cGMP compliance, corrective actions, and cross-functional collaboration. Focus on defining investigation strategies, identifying root causes, developing CAPA plans, and driving complex investigations to timely closure.

Location: USA - OH - West Chester; work is performed in office, laboratory, and cGMP manufacturing environments.

Salary: $80,000–$117,500 per year.

Company

hirify.global is a technology-focused biomanufacturing company building sustainable, end-to-end manufacturing solutions for medicines.

What you will do

  • Lead organized investigations with defined scope, strategy, timelines, status tracking, and documented progress.
  • Author investigation reports covering issue definition, scope, product impact, root cause, and corrective actions.
  • Use approved investigation and Lean problem-solving tools to drive teams toward root cause.
  • Coordinate cross-functional communication, investigation strategies, action plans, solution selection, and effectiveness checks.
  • Prioritize and escalate issues while managing investigations through timely closure.
  • Coach colleagues and build alignment on root-cause and corrective-action decisions.

Requirements

  • Experience in pharmaceutical manufacturing or another regulated industry.
  • Familiarity with cGMP documentation practices and applicable regulatory requirements.
  • Ability to assess technical data, conduct thorough investigations, and present complex findings clearly.
  • Ability to manage multiple concurrent investigations and meet objectives and timelines.
  • Excellent written, verbal, presentation, and technical investigation report-writing skills.
  • Ability to work independently in a fast-paced environment and own investigations through completion.

Nice to have

  • Bachelor’s degree in science, engineering, or a related technical discipline; relevant experience may substitute.
  • 5+ years of experience in pharmaceutical or regulated manufacturing, including quality investigations and deviation management.
  • Experience across multiple sites or functions.
  • Familiarity with Lean problem-solving tools and internal core business processes.

Culture & Benefits

  • Full-time schedule of 8 hours, Monday through Friday.
  • Annual cash bonus program and 401(k) plan with company match.
  • Medical, dental, vision, life, and disability insurance.
  • Paid vacation, holidays, and other leaves of absence.
  • Tuition reimbursement, family-building benefits, and caregiving support.
  • Visa and work authorization sponsorship are not available.

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