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5 дней назад

Quality Control Chemist (Analytical Chemistry)

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 Chemist (Analytical Chemistry): Reviewing and approving analytical chemistry documentation, laboratory data, methods, validation records, and quality investigations with an accent on cGMP, cGLP, ISO 17025, A2LA, and USP compliance. Focus on maintaining data integrity, evaluating root causes and CAPA plans, supporting audits, and improving quality systems across chemistry testing operations.

Location: Houston, Texas, United States

Company

hirify.global provides pharmaceutical and compounding-industry testing, calibration, and scientific solutions through an FDA-registered cGMP laboratory.

What you will do

  • Review and approve analytical chemistry methods, validation documents, laboratory data, reports, worksheets, and quality records.
  • Maintain compliance with SOPs, the Quality Management System, cGMP, cGLP, ISO 17025, A2LA, and USP standards.
  • Review quality investigations involving OOS results, nonconformances, deviations, CAPA, change controls, and customer complaints.
  • Evaluate root-cause analyses and corrective action plans for laboratory and process issues.
  • Support regulatory inspections, client audits, accreditation assessments, internal audits, and routine compliance walkthroughs.
  • Maintain controlled quality documentation, training materials, quality manuals, and continuous-improvement initiatives.

Requirements

  • Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline required.
  • Strong understanding of analytical chemistry techniques and instrumentation, including HPLC, HPLC-MS/MS, GC-MS, and UV-Vis.
  • Working knowledge of method validation, data review, laboratory quality systems, and GMP/GLP documentation.
  • Strong attention to detail, data integrity, regulatory compliance, and written and verbal communication skills.
  • Ability to work independently and collaborate with cross-functional teams.
  • Proficiency with Microsoft Office and electronic document management systems.

Nice to have

  • Experience in an ISO 17025, cGMP, or cGLP-regulated laboratory.
  • Experience supporting analytical chemistry testing laboratories.
  • ASQ qualification or HPLC certification.
  • Bachelor’s degree in Biochemistry or a related field.

Culture & Benefits

  • Work within a state-of-the-art scientific testing and calibration laboratory.
  • Collaborate with pharmaceutical manufacturers, compounding facilities, hospitals, and clinical research organizations.
  • Contribute to patient-safety-focused compliance and science-based solutions.
  • Participate in quality improvement and regulatory initiatives serving clients across North America and globally.

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