Clarkston Consulting
Clarkston Consulting
Clarkston Consulting este o companie de consultanță strategică în afaceri care sprijină organizații din domeniul științelor vieții, al produselor de consum și al comerțului cu amănuntul. Activitatea sa acoperă strategia de afaceri, operațiunile, implementarea, serviciile gestionate, managementul schimbării și transformarea bazată pe date. Compania oferă, de asemenea, expertiză în consultanță pentru procese de afaceri, cercetare clinică, consultanță digitală și tehnologică și managementul lanțului de aprovizionare, ajutând clienții să abordeze provocări operaționale și organizaționale complexe.

LIMS Consultant

Configure and validate LabWare or LabVantage systems for Clarkston Consulting’s life sciences clients. Automate laboratory workflows in regulated GxP environments.

Descriere

  • Configure LIMS modules for assay development, plate results, sample management, stability, and analytical testing.
  • Design, configure, and validate assay workflows to meet scientific needs and GxP requirements.
  • Create and maintain LIMS scripts for workflow automation, business rules, calculations, instrument connections, and data transformation.
  • Prepare project documentation and demonstrate configurations to clients.
  • Work with scientists, QA/CSV teams, and IT to gather requirements, develop technical solutions, and support validation activities (URS, FRS, DS, IQ/OQ/PQ).
  • Ensure configurations meet 21 CFR Part 11 and other validation requirements.
  • Coordinate with LIMS consultants across sites to support deployments.

Cerințe

  • Bring at least two years of hands-on experience with LabWare or LabVantage LIMS.
  • Have experience configuring and customizing LabWare or LabVantage LIMS for laboratory workflows.
  • Demonstrate the ability to design, configure, and validate assay workflows.
  • Have experience developing and maintaining scripts for workflow automation, business rules, calculations, instrument integrations, and data transformation.
  • Understand laboratory operations and end-to-end lab processes.
  • Be skilled at preparing thorough project documentation and presenting configuration demonstrations to clients.
  • Show strong attention to detail, analytical ability, and problem-solving skills.
  • Communicate and collaborate effectively across cross-functional teams.
  • Have experience in a regulated field such as pharmaceuticals, biotechnology, or food safety.
  • Know GxP, 21 CFR Part 11, and other applicable regulatory requirements.
  • Hold a four-year degree in Life Sciences, Information Technology, or a related field.

Beneficii

  • Comprehensive health and wellness coverage, including medical, dental, and vision.
  • 401(k) plan with company contributions.
  • Paid vacation, personal days, holidays, and sick leave.
  • Paid parental leave and family-building support for adoption, surrogacy, and infertility.
  • Life and disability insurance.
  • Training and professional development funding, tuition assistance, and more.
  • Home office work when not traveling or working at a client site.
  • Relocation is not required.

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