Method Transfer Validation

Eurofins USA PSS Insourcing Solutions

Method Transfer Validation

Sanford, NC
Full Time
Paid
  • Responsibilities

    Job Description

    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.

  • Qualifications

    Qualifications

    Minimum Qualifications:

    • 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

    Preferred Qualifications:

    • 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

    Additional Information

    Position is full-time, Monday-Friday 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.

    What we offer:

    • 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

    Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.