Associate - Empower Global Informatics

Lilly • Concord, NC

2d • $65,250 - $169,400 • Hybrid

About The Position

The AQCO informatics team provides support for globally owned informatics applications and processes in Manufacturing Quality laboratories worldwide. The Empower Global Informatics Associate is part of a team of informatics professionals who work to identify, develop, validate, deploy, maintain, and defend globally owned, GMP compliant, informatics applications throughout their lifecycle. The members of the AQCO Informatics team represent the needs and interest of the business areas we support and acts as their voice and advocate.

Requirements

• Bachelor’s Degree or equivalent experience in Chemistry, Biology, Chemical Engineering or closely related field
• Minimum 2 years’ GMP laboratory experience
• Knowledge of quality documentation and control processes
• Demonstrated knowledge of analytical testing methods, laboratory documentation and control processes
• Extensive knowledge of Empower.

Nice To Haves

• Experience with analytical separations and instrumentation, Empower, and pharmaceutical testing
• Good organizational skills.
• Learning flexibility/agility; strong communication/presentation skills; strong system skills to navigate in multiple systems;
• Possess a clear understanding of quality activities; experience in IT systems implementation; and a motivation to deliver.
• Clear understanding of quality laboratory issues and activities
• Ability to work independently or in a team setting

Responsibilities

• Provide support for the Empower application, which is used by MQ laboratories for chromatographic testing, including GC, HPLC, and CE.
• Work with the informatics team, Tech@Lilly, and site personnel to implement Empower and provide ongoing support.
• Support the development and refinement of system requirements for Empower and related applications, as well as testing protocols, scripts, and business specific system configuration items.
• Perform validation testing, user acceptance, and authoring/editing of various validation deliverables.
• Develop, maintain, and deliver training materials for Empower and related applications and business processes.
• Provide business knowledge, coordination, and support for implementation of standardized business processes during the deployment of Empower and related applications.
• Assist analysts at sites in data discovery, verification, and other tasks to support system acceptance.
• Interact with site resources to support the deployment of Empower and related applications by understanding local requirements and applying them to global business processes as a member of the site deployment team.
• Communicate new and changed business processes to deployment sites and influence the site to adopt these standardized global processes and tools to support the site’s intended use of the system.
• Provide ongoing support for Empower, including the reporting and management of support issues, incident and deviation investigation, coaching and mentoring of system users, and the identification of transferrable work processes between sites.
• Provide answers to questions from inspections, audits, and other formal and informal assessments that impact globally owned applications and their associated workflows.
• Cross-train on unrelated applications to help provide support of non-Empower applications.
• Visit laboratory and manufacturing sites involving unique PPE and/or gowning requirements.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical benefits
• dental benefits
• vision benefits
• prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance
• death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level