Method Transfer Validation

EurofinsSanford, NC
3hOnsite

About The Position

This role is located on-site in Sanford, NC. Handle the creation, review, and approval of test method transfer protocols, validation documentation, and equipment qualification records. Support ELISA, plate-based, and other bioanalytical testing and conduct QC Analytical related investigations. Maintain compliance with Current Good Manufacturing Practices across Quality Control and Stability laboratory operations. Perform testing on various samples, manage Laboratory Information Management System builds, and review laboratory data. Serve on cross-functional teams: Conducting safety inspections Participate in investigations, recommend corrective actions Training of junior colleagues Reliable transportation needed to commute to the site, the site is not accessible by public transportation options.

Requirements

  • Bachelors degree in a scientific concentration
  • Prior experience with method validation and QC testing
  • Experience with ELISA and plate-based testing
  • Knowledge of pharmaceutical manufacturing, packaging, and quality assurance operations
  • Knowledge of quality systems
  • Authorization to work in the United States indefinitely without restriction or sponsorship
  • Reliable transportation needed to commute to the site, the site is not accessible by public transportation options.

Nice To Haves

  • Proficiency in data analysis and interpretation
  • Knowledge of regulatory requirements and guidelines
  • Strong problem-solving abilities
  • Effective time management and organizational skills
  • Experience with Laboratory Information Management Systems (LIMS)
  • Ability to mentor and train junior colleagues

Responsibilities

  • Handle the creation, review, and approval of test method transfer protocols, validation documentation, and equipment qualification records.
  • Support ELISA, plate-based, and other bioanalytical testing and conduct QC Analytical related investigations.
  • Maintain compliance with Current Good Manufacturing Practices across Quality Control and Stability laboratory operations.
  • Perform testing on various samples, manage Laboratory Information Management System builds, and review laboratory data.
  • Serve on cross-functional teams
  • Conducting safety inspections
  • Participate in investigations, recommend corrective actions
  • Training of junior colleagues

Benefits

  • Excellent full time benefits including comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
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