What are the responsibilities and job description for the Associate - Empower Global Informatics position at BioSpace?
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
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.
Core Support
The Empower Global Informatics Associate will provide support for the Empower application. The Empower application is used by MQ laboratories for chromatographic testing, including GC, HPLC, and CE. The Empower Global Informatics Associate will work with the informatics team, Tech@Lilly, and site personnel to implement Empower and provide ongoing support.
Development And Validation
The Empower Global Informatics Associate will work with the development team to help 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. The Empower Global Informatics Associate will help perform validation testing, user acceptance, and authoring/editing of various validation deliverables.
Training
The Empower Global Informatics Associate will help develop, maintain, and deliver training materials for Empower and related applications and business processes. Training delivery may involve travel to sites on an as-needed basis, and establishing a regular training schedule at MQLC or other global facilities. The Empower Global Informatics Associate will work closely with global and local training professionals and third-party providers throughout this process to ensure effectiveness of the training regimen.
Deployment And Support
The Empower Global Informatics Associate is responsible for providing business knowledge, coordination, and support for implementation of standardized business processes during the deployment of Empower and related applications. This includes assisting analysts at sites in data discovery, verification, and other tasks to support system acceptance.
The Empower Global Informatics Associate will 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. They will 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.
Support Team Participation And Issue Resolution
The Empower Global Informatics Associate will be expected to 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.
Inspection Support
The Empower Global Informatics Associate will be part of the team that will provide answers to questions from inspections, audits, and other formal and informal assessments that impact globally owned applications and their associated workflows. This may require travel to sites, extensive evaluation and research of answers, and crafting formal responses for inclusion in company documentation.
Basic Qualifications
The following knowledge and/or training is required for success in this role –
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
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.
Core Support
The Empower Global Informatics Associate will provide support for the Empower application. The Empower application is used by MQ laboratories for chromatographic testing, including GC, HPLC, and CE. The Empower Global Informatics Associate will work with the informatics team, Tech@Lilly, and site personnel to implement Empower and provide ongoing support.
Development And Validation
The Empower Global Informatics Associate will work with the development team to help 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. The Empower Global Informatics Associate will help perform validation testing, user acceptance, and authoring/editing of various validation deliverables.
Training
The Empower Global Informatics Associate will help develop, maintain, and deliver training materials for Empower and related applications and business processes. Training delivery may involve travel to sites on an as-needed basis, and establishing a regular training schedule at MQLC or other global facilities. The Empower Global Informatics Associate will work closely with global and local training professionals and third-party providers throughout this process to ensure effectiveness of the training regimen.
Deployment And Support
The Empower Global Informatics Associate is responsible for providing business knowledge, coordination, and support for implementation of standardized business processes during the deployment of Empower and related applications. This includes assisting analysts at sites in data discovery, verification, and other tasks to support system acceptance.
The Empower Global Informatics Associate will 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. They will 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.
Support Team Participation And Issue Resolution
The Empower Global Informatics Associate will be expected to 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.
Inspection Support
The Empower Global Informatics Associate will be part of the team that will provide answers to questions from inspections, audits, and other formal and informal assessments that impact globally owned applications and their associated workflows. This may require travel to sites, extensive evaluation and research of answers, and crafting formal responses for inclusion in company documentation.
Basic Qualifications
The following knowledge and/or training is required for success in this role –
- 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.
- The ideal candidate will have 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
- The Empower Informatics Associate may be asked to cross-train on unrelated applications to help provide support of non-Empower applications. Individual must be willing to visit laboratory and manufacturing sites involving unique PPE and/or gowning requirements.
- Frequent travel (domestic and/or international) will be required for this position.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Salary : $65,250 - $169,400