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2 дня назад

Quality Control Microbiology Analyst (Biopharma)

27 - 42$
Формат работы
onsite
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
Quality Control Microbiology Analyst (Biopharma): Performing microbiological and analytical testing for pharmaceutical ingredients, drug products, and in-process samples with an accent on product release, environmental monitoring, stability testing, and cleaning verification. Focus on interpreting results against specifications, troubleshooting abnormalities, maintaining cGMP/GLP documentation, and supporting FDA and international regulatory compliance.

Location: Frederick, Colorado, United States. Onsite laboratory role with a Wednesday–Saturday schedule from 9 a.m. to 7 p.m.; occasional travel may be required.

Salary: $27.15–$42.43 per hour, plus bonus eligibility, stock, and benefits.

Company

hirify.global supports biopharmaceutical companies in developing and commercializing nucleic acid therapeutics and is expanding its Colorado operations.

What you will do

  • Conduct routine and non-routine microbiological and analytical testing under SOP, cGMP, and GLP requirements.
  • Test active pharmaceutical ingredients, final drug products, and in-process samples.
  • Perform environmental monitoring, cleaning verification, and stability testing to support product release.
  • Review and interpret data against product specifications, troubleshoot abnormalities, and escalate issues.
  • Maintain laboratory equipment, initiate corrective actions, and complete accurate GDP documentation.
  • Communicate results and timelines with project managers and stakeholders while supporting laboratory and quality-system improvements.

Requirements

  • Secondary education and quality-control experience.
  • Knowledge of analytical equipment and laboratory instrumentation.
  • Ability to work the Wednesday–Saturday, 9 a.m.–7 p.m. shift.
  • Ability to follow SOPs, cGMP/GLP requirements, Good Documentation Practices, and applicable quality procedures.
  • Ability to collaborate cross-functionally and communicate testing results and issues effectively.

Nice to have

  • Bachelor of Science in microbiology, life sciences, or a related field.
  • At least one year of experience in a quality-control laboratory, preferably in pharmaceuticals or biotechnology.
  • Knowledge of cGMP, FDA, and international regulations.
  • Experience with bacterial endotoxin, bioburden, TOC, compressed gas, environmental monitoring, UV, or USP <61> testing.
  • Proficiency with Microsoft Word and Excel.

Culture & Benefits

  • Full-time employment with bonus eligibility, stock, and benefits.
  • Work within a cross-functional Quality organization supporting pharmaceutical product safety and compliance.
  • Focus on continuous improvement of laboratory processes, procedures, and quality systems.
  • Inclusive, merit-based workplace committed to equal employment opportunity and accessibility.

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