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1 день назад

Manufacturing Quality Engineer (CGMP)

82 480 - 128 875$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
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 Quality Engineer (CGMP) (Life Sciences Manufacturing): Developing and improving quality assurance tools, equipment, processes, and documentation for expanding manufacturing operations with an accent on CGMP compliance, process quality, and product lifecycle support. Focus on leading process improvements, supporting manufacturing start-up activities, reviewing nonconformances, and transitioning products from prototype to full production.

Location: Onsite in Frederick, Colorado, United States. The role begins on a day schedule, Monday–Friday, 8:00 am–5:00 pm, and transitions to a swing shift, Monday–Friday, 4:00 pm–12:30 am, with some flexibility in start and end times.

Salary: $82,480–$128,875 per year, plus eligibility for bonus, stock, and benefits.

Company

hirify.global develops scientific instruments, software, services, and solutions for life science, diagnostics, and applied chemical markets.

What you will do

  • Provide quality assurance guidance, expertise, services, and oversight for processes, data, and products.
  • Lead process and product improvement initiatives supporting the Endeavor expansion project and Frederick manufacturing operations.
  • Support manufacturing start-up activities as the quality representative and develop quality assurance tools and equipment.
  • Create, review, and approve equipment and process SOPs, manufacturing documentation, and new product introduction materials.
  • Support the transition of products and manufacturing processes from prototype through full production and the complete product lifecycle.
  • Partner with material management, planning, procurement, manufacturing, technical services, and quality teams to meet production timelines and customer expectations.

Requirements

  • Bachelor’s or master’s degree, or equivalent education, in the sciences.
  • At least 2 years of relevant experience.
  • Experience in a CGMP-regulated environment is required.
  • Ability to work independently with minimal oversight.
  • Ability to work onsite in Frederick, Colorado, including the scheduled transition to swing shift.
  • Ability to work with process materials while following applicable safety guidelines and quality regulations.

Culture & Benefits

  • Full-time employment with stock, bonus eligibility, and benefits.
  • Work focuses on quality, process improvement, manufacturing expansion, and life science operations.
  • Inclusive, merit-based workplace that welcomes individuals from all backgrounds.
  • No travel is required.

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