Analytical Compliance Manager

New

Skills

Continuous improvement Ich Guidelines

Job Overview

As an Analytical Compliance Manager, you will be responsible for authoring and reviewing analytical methods, protocols, reports, and SOPs. You will also maintain analytical instrumentation and computer control systems, onboard and implement LabVantage for LIMS/ELN/inventory, improve technical operation workflows and project outcomes, and support lab operations.

Responsibilities
  • Author and review analytical methods, protocols, reports, and SOPs
  • Maintain analytical instrumentation and computer control systems
  • Onboard and implement LabVantage for LIMS/ELN/inventory
  • Improve technical operation workflows and project outcomes
  • Support lab operations – inventory, sample management, docs
Requirements & Qualifications
  • Master’s in biological sciences or related field
  • 2+ years in biotech
  • Experience in project management
  • Experience in Continuous Improvement and Lean Six Sigma
  • Experience drafting protocols, methods, reports, and SOPs
  • Experience in system validation, CSV, onboarding/implementation
  • Experience performing root cause analysis and CAPA
  • Familiarity with ICH guidelines and FDA regulations
  • GxP knowledge
  • Experience in BlueMountain, QUMAS, Veeva, Smartsheet, Notion, and/or Monday
  • Experience in change control, deviation, laboratory investigation, and/or other quality records

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: 12 Months

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