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1 день назад

QC Data Reviewer (LNP and Lipids)

36 - 40$
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
QC Data Reviewer (LNP and Lipids) (GMP pharmaceutical quality control): Reviewing and evaluating analytical data packages for LNP formulations and lipid materials across stability studies, method development, and investigations with an accent on data integrity, chromatographic data interpretation, and regulatory compliance. Focus on evaluating OOS/OOT investigations, verifying calculations and transcriptions, and resolving discrepancies with analytical and quality teams.

Location: Boston, MA, USA; candidates must live within a commutable distance of Boston.

Salary: USD 36.00–40.00 per hour, depending on education and experience.

Company

hirify.global provides analytical testing and life sciences services across pharmaceutical, environmental, food, cosmetics, genomics, and related industries.

What you will do

  • Review analytical data packages from stability studies, method development, and investigations for LNP and lipid-based products.
  • Evaluate OOS/OOT investigation reports for completeness, scientific soundness, and corrective actions.
  • Verify calculations, data transcriptions, and chromatographic data for accuracy and compliance.
  • Ensure documentation meets GMP and applicable regulatory requirements.
  • Maintain review timelines and tracking logs for product release and regulatory submission deadlines.
  • Partner with analytical and quality teams to resolve discrepancies and review findings.

Requirements

  • B.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
  • 3–4 years of analytical laboratory experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
  • Proficiency in GMP regulations and Good Documentation Practices.
  • Understanding of chromatography operation and chromatographic data interpretation.
  • Strong organization, attention to detail, accuracy, time management, and multitasking skills.
  • Authorization to work indefinitely in the United States without restriction or sponsorship.

Nice to have

  • Experience interpreting HPLC, UPLC, and LC-MS chromatograms and reviewing chromatography data.
  • Familiarity with LNP and lipid technologies and investigations.
  • Experience with method development.
  • Experience with SLIM, Veeva, JMP, or LIMS.

Culture & Benefits

  • Full-time schedule, Monday through Friday, 8:00 a.m. to 5:00 p.m.
  • Medical, dental, and vision coverage options.
  • Life and disability insurance.
  • 401(k) plan with company match.
  • Paid vacation and holidays.
  • Professional growth opportunities and a focus on work-life balance.

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