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2 дня назад

Quality Control Microbiologist

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 Microbiologist (Microbiology/Quality Systems): Reviewing sterile and non-sterile microbiological testing data, documentation, and investigations to maintain compliance with cGMP, cGLP, ISO 17025, A2LA, and USP requirements. Focus on evaluating OOS, NCR, deviations, CAPA, audits, root-cause analyses, and data integrity across regulated laboratory operations.

Location: Houston, Texas, United States

Company

Scientific testing and solutions provider operating an FDA-registered cGMP testing and calibration laboratory serving pharmaceutical, medical, compounding, hospital, and clinical research clients.

What you will do

  • Review sterile and non-sterile microbiology test data, worksheets, logbooks, reports, and quality records.
  • Apply cGMP, cGLP, ISO 17025, A2LA, USP, SOP, and quality management system requirements.
  • Review and approve OOS investigations, NCRs, deviations, CAPAs, change controls, and customer complaints.
  • Evaluate root-cause analyses and corrective action plans for laboratory and process issues.
  • Support and conduct internal audits, regulatory inspections, client audits, accreditation assessments, and compliance walkthroughs.
  • Write, review, and approve SOPs, work instructions, forms, quality manuals, training materials, and controlled documentation.

Requirements

  • Bachelor’s degree in Microbiology, Biology, or a related life science.
  • Knowledge of cleanroom practices and microbiological testing principles.
  • Strong attention to detail and commitment to data integrity and regulatory compliance.
  • Excellent written and verbal communication skills.
  • Ability to work independently and collaborate with cross-functional teams.
  • Proficiency with Microsoft Office applications and electronic document management systems.

Nice to have

  • Experience with sterile or non-sterile microbiology testing.
  • Experience in an ISO 17025, cGMP, or cGLP-regulated laboratory.
  • Experience reviewing GMP/GLP documentation and quality investigations.
  • ASQ certification or related quality credentials.

Culture & Benefits

  • Full-time position supporting quality control and regulatory objectives.
  • Work alongside laboratory operations, quality leadership, and cross-functional teams.
  • Contribute to continuous improvement in quality systems, documentation, and laboratory compliance.
  • Mission focused on patient safety and science-based solutions.

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