Product Protection Specialist

Eurofins USA PSS Insourcing Solutions•Indianapolis, IN

4d•Onsite

About The Position

Perform routine operational support and Investigative tasks involved in the investigation of suspect samples (e.g., sample log-in, photographs, packaging variable data verification, packaging evaluations, physical appearance, etc.). This position will only perform first person analysis. Perform non-routine sample analyses of suspect samples utilizing screening technologies. Produce quality documentation for internal and external use and ensure data documentation meets ALCOA plus expectations. Learn and utilize basic development, manufacturing, and regulatory processes, and develop an awareness of analytical and pharmaceutical industry trends related to product authentication. Work collaboratively with people in AQCO and with cross-functional business partners. Work safely and in compliance with applicable quality, environmental, and safety expectations. Ensure compliance with applicable Lilly global standards and regulatory guidelines. As needed within the AQCO organization, this position will help with shipping and purchasing needs.

Requirements

BS in the field of Chemistry, Biology, or a related field
Fundamental knowledge of cGMP/GLP compliance requirements.
1-3 years of pharmaceutical experience.
Capable of evaluating safety/quality compliance and supporting efforts to perform needed activities.
Effective oral and written communication skills, self-management, task planning, and organization.
Must be able to work productively in an interdisciplinary team environment.
Ability to execute well-defined protocols/procedures with minimal oversight.
Experience with basic analytical techniques (e.g., balances, pH meter, etc.).
Theoretical experience with more sophisticated analytical techniques (e.g., microscopy, IR, NIR, Raman, HPLC, GC-MS, LC-MS, SEM-EDS), as required.
Experience using IT tools such as: Veeva (QDocs), SmartLab, BLUE, NuGenesis, Empower, Tableau, CIMS, Trackwise, SAP, Fiori, etc.
Experience with handling confidential/privileged information.

Responsibilities

Perform routine operational support and Investigative tasks involved in the investigation of suspect samples (e.g., sample log-in, photographs, packaging variable data verification, packaging evaluations, physical appearance, etc.).
Perform non-routine sample analyses of suspect samples utilizing screening technologies.
Produce quality documentation for internal and external use and ensure data documentation meets ALCOA plus expectations.
Learn and utilize basic development, manufacturing, and regulatory processes, and develop an awareness of analytical and pharmaceutical industry trends related to product authentication.
Work collaboratively with people in AQCO and with cross-functional business partners.
Work safely and in compliance with applicable quality, environmental, and safety expectations.
Ensure compliance with applicable Lilly global standards and regulatory guidelines.
As needed within the AQCO organization, this position will help with shipping and purchasing needs.