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12 часов назад

Quality Control Analyst (Biopharmaceutical)

Формат работы
onsite
Тип работы
project
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
Quality Control Analyst (Biopharmaceutical): Performing bioassays and routine testing of bulk drug substance and drug product samples in a cGMP laboratory with an accent on cell passaging, aseptic technique, and data review. Focus on applying cGMP regulations, reviewing batch release and stability data, and maintaining accuracy in a fast-paced laboratory environment.

Location: Devens, Massachusetts, United States; onsite work in a cGMP laboratory and manufacturing environment

Company

hirify.global is a US-based IT staffing company providing technical and contingent workforce solutions for client projects.

What you will do

  • Perform routine bioassays in a fast-paced QC operations environment.
  • Carry out cell passaging using aseptic technique, preferably with automation.
  • Test batch release and stability samples from bulk drug substance and drug product.
  • Review testing data and maintain accurate electronic data collection records.
  • Work in accordance with laboratory safety procedures, including proper use of PPE.
  • Support assignments independently and collaboratively, including possible weekend work.

Requirements

  • Bachelor’s degree in chemical sciences, a related discipline, or equivalent scientific education.
  • At least two years of experience in a biologics QC laboratory or related biopharmaceutical cGLP or cGMP laboratory.
  • Knowledge of cGMP regulations and compendial testing.
  • Proficiency in cell passaging techniques; experience with automation is preferred.
  • Technical experience with LIMS, Excel, and electronic data collection.
  • Strong written and verbal communication skills and attention to detail.

Culture & Benefits

  • Six-month contract with a possible extension of up to three years.
  • Fast-paced laboratory and manufacturing environment.
  • Defined time constraints and opportunities to work both independently and as part of a team.
  • Weekend assignments may be required.

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