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Zifo

Specialist scientific informatics services for science

Validation Analyst

Regulatory & Quality (Life Sciences)Posted on Nov 10
Full-timeNorwood Young America, MN, USA$80k - $100kIn-person

About the Job

Requirements

  • Prior experience with benchtop instruments is required.
  • Prior experience validating robotic workstations is required.
  • A bachelor's or master's degree, or equivalent, in a scientific or health care field is required.
  • Five or more years of experience in a validation, quality assurance, or quality control role is required; pharmaceutical or life sciences industry experience is preferred.
  • Experience with validation of analytical instrument systems, including benchtop analytical systems such as spectroscopy, chromatography, protein analyzers, next-generation sequencers, and PCR systems.
  • Understanding of the software development life cycle process and methodologies such as Agile is required.

Responsibilities

  • Create and support the review of validation life cycle documents for analytical instrument qualification and computerized systems.
  • Consult clients on data integrity requirements in analytical instruments and verify data integrity in the systems.
  • Author validation life cycle documents for client review and approval.
  • Perform periodic reviews of analytical instruments and conduct stakeholder meetings to discuss remediation of observations.
  • Review IT audit trails and conduct stakeholder meetings to discuss remediation of observations.
  • Act as a business consultant supporting system end users.
  • Route drafted documents for review and reviewed documents for workflow approval, and request approval workflows from document control.
  • Execute approved protocols in a GxP facility.
  • Work with global teams to deliver validation project deliverables.
  • Manage project life-cycle change controls through process compliance and interface with the Quality Assurance change control area.
  • Author change control documents for client review and approval.

Desired Qualifications

  • Pharmaceutical or life sciences industry experience is preferred.

About the Company

Zifo

Specialist scientific informatics services for science

Zifo provides tailored scientific informatics services across Laboratory/R&D, Manufacturing, and Trial operations to help science-driven organizations discover, develop, manufacture, and test products for global health. It partners with clients to assess needs, design and implement data-driven solutions, and manage ongoing operations using consulting, development, and managed services, leveraging cloud, HPC, data modeling, and instrument data. It differentiates itself with end-to-end informatics capabilities and deep domain knowledge, from transformation coaching to validation and custom integrations, all aimed at supporting research, development, manufacturing, and trials. Its goal is to empower customers to push the boundaries of science and technology while advancing global health and wellbeing.

Company size
1,001-5,000
Company stage
Growth Equity (Non-Venture Capital)
Total funding
$250M
Headquarters
New York, NY
Founded
2008

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