Job Description

The hand-held Raman testing laboratory analysts in the Analytical Quality Control Operations (AQCO) organization will serve as a technical resource to execute material identification test method validations and transfers, to support installation of hand-held Raman applications in Quality Control testing labs and materials receipt areas. The hand-held Raman testing analyst has primary responsibility for executing approved protocols for method validation and transfer, generating the data necessary to complete studies, training analysts in receiving laboratories, and participating in investigations of protocol deviations or protocol execution issues. The analyst may also participate in generating documentation, including methods, protocols, reports and change controls in support of these activities. The hand-held Raman testing analyst should have familiarity with basic laboratory operations and must be capable of operating in a cGMP laboratory environment.

• Execute approved protocols for method validation and transfer, with accurate documentation of execution steps and data in an electronic notebook or other electronic execution system.
• Provide hands-on training and oversight to receiving laboratories before and during method transfers, including troubleshooting for execution difficulties.
• Assist with investigations into protocol or method execution errors or difficulties in successful testing.
• Author methods, protocols, and reports to support new materials or transfer existing methods to new laboratories.
• Technically review validation or transfer data generated by other analysts.

Qualifications

• Bachelor’s degree in chemistry or related physical sciences field, or at least 1-3 years of laboratory experience in a cGMP pharmaceutical Quality Control laboratory.
• Fundamental knowledge of requirements in a cGMP environment.
• Effective communication and self-management
• Effective interpersonal skills with the ability to work within a cross-functional, interdisciplinary team environment
• Strong computer, scientific, and organizational skills
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Additional Skills/ Preferences:

• Experience using Electronic Laboratory Notebooks and electronic document repositories.
• Prior experience with Raman spectroscopic testing

Additional Information

• Position is full-time, Monday-Friday, 8:00 am - 5:00 pm, with potential for weekends or holiday work if needed
• Candidates currently living within a commutable distance of Indianapolis, IN, are encouraged to apply
• 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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• Authorization to work in the United States indefinitely without restriction or sponsorship

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