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1 день назад

Senior Business Analyst (LIMS Quality & Configuration)

Формат работы
remote (только USA)/hybrid
Тип работы
fulltime
Грейд
senior
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
Senior Business Analyst (LIMS Quality & Configuration): Researching requirements and regulated documentation to support LabVantage LIMS design, configuration, and verification with an accent on data packet assembly, traceability, and GxP compliance. Focus on analyzing Jira user stories and Veeva-controlled materials, reconciling requirements, and identifying configuration discrepancies and validation gaps.

Location: United States. Remote work is supported; employees within a reasonably short commute of an office are encouraged to work on a hybrid basis as agreed with their manager.

Company

hirify.global provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

  • Research Jira user stories and assemble Data Packets using Veeva-controlled documents, specifications, protocols, and supporting materials.
  • Analyze and reconcile requirements and source documentation to ensure Data Packets are complete and accurate.
  • Support the development of structured, traceable Design Specifications for LabVantage LIMS configuration.
  • Verify LabVantage LIMS configurations against approved Design Specifications and document results, discrepancies, defects, and implementation gaps.
  • Partner with developers, configuration specialists, project teams, and client stakeholders to resolve verification findings.
  • Maintain documentation quality and adherence to GxP, quality, and validation standards.

Requirements

  • 3–7 years of experience in pharmaceutical, biotechnology, laboratory, quality, validation, or regulated systems environments.
  • Bachelor’s degree required; Life Sciences, Computer Science, Information Systems, or a related field preferred.
  • Experience with LIMS platforms; LabVantage experience is strongly preferred.
  • Experience gathering, analyzing, and documenting business or system requirements.
  • Experience with software testing, system verification, validation, or quality assurance in a regulated environment.
  • Strong analytical thinking, attention to detail, communication, adaptability, and a quality and compliance mindset.

Nice to have

  • Familiarity with Veeva, Tableau, ELN, LES/MES, eQMS, or other regulated laboratory and quality management systems.
  • Prior business analyst, validation, quality systems, or project coordination experience.

Culture & Benefits

  • Remote work is supported, with hybrid collaboration encouraged for employees located near an office.
  • Work across multiple functions and workstreams in a regulated pharmaceutical client environment.
  • Emphasis on diversity, equity, inclusion, collaboration, continuous learning, and proactive issue resolution.
  • Applications are personally reviewed by the recruitment team without AI screening tools.

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