Method Transfer Validation

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.

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

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.