Indianapolis Staffing
LabVantage Deployment Specialist
Indianapolis Staffing, Indianapolis, Indiana, United States, 46201
LabVantage Deployment Specialist
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 LabVantage Deployment Specialist is part of a team of informatics professionals who work closely with Tech@Lilly (IT) to deploy, maintain, and maintain in compliance the LabVantage application throughout their lifecycle. They represent the needs and interests of the business areas they support and act as their voice and advocate. Key Responsibilities:
Lead the sites on the implementation of LabVantage through the different phases of deployment. Maintain deployment documentation, including site readiness checklists, issue logs, and lessons learned. Instruct on the to be processes in LabVantage (e.g. sample management, batch release, stability, lab execution). Act as a SME in one of the following areas: QA, QC Lab or Stability. Assist sites during data discovery to identify the scope and the master data elements that need to be created as part of the LabVantage deployment. Triage site change request, evaluate feasibility and global impact. Prioritize requests according to site needs. Work with the project manager to identify and report key process indicators to report the progress of site deployments. Collaborate and manage third-party partners to successfully deploy LabVantage. Work with the Global LabVantage team to ensure that the process designed in LabVantage are compliant with data integrity and GMP requirements. Understand local requirements and apply them to standardized global business processes. Communicate new and changed business processes to sites and influence the sites to adopt these globally standardized processes and global tools to support the site's intended use of LabVantage. Provide ongoing support and issue resolution related to business processes in LabVantage. Involve Tech@Lilly for system related issues. Identify software gaps and/or business processes changes that must be created to support site deployment. Raises issues to the Site Council and or LabVantage leadership team. Share key learning and standard practices to increase their system knowledge, and identify transferable work processes between sites. Provide answers to questions from inspections, audits, and other formal and informal assessments that impact globally owned applications and their Specialised workflows. Support system releases by implementing UAT and updating impacted procedures. Act as an extended master data support when required by the master data workstream. Minimum Requirements:
Bachelor's degree Minimum 3 years of laboratory experience Education Preference:
Bachelor's degree in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related field. Skills:
Experience working in/with GMP laboratories Strong scientific background Clear understanding of quality laboratory issues and activities Experience in defining and improving business processes Knowledge of cGMP and quality systems Solid understanding of GMP requirements and data integrity principles. Proven work with computer systems and their adaptability to existing business processes. Extensive knowledge of analytical methods, laboratory documentation and control processes. Knowledge of product release processes. Experience managing stability program. Ability to manage multiple priorities simultaneously. Additional Information:
This position will require occasional travel to manufacturing sites, development laboratories, and application vendors. Individuals must be willing to visit laboratory and manufacturing sites involving unique PPE and/or gowning requirements. This role is primarily on-site, with the flexibility to work from home four days a month. Location posted as Indianapolis but open to other locations where Lilly has a manufacturing site. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. 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. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $162,800. 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.
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 LabVantage Deployment Specialist is part of a team of informatics professionals who work closely with Tech@Lilly (IT) to deploy, maintain, and maintain in compliance the LabVantage application throughout their lifecycle. They represent the needs and interests of the business areas they support and act as their voice and advocate. Key Responsibilities:
Lead the sites on the implementation of LabVantage through the different phases of deployment. Maintain deployment documentation, including site readiness checklists, issue logs, and lessons learned. Instruct on the to be processes in LabVantage (e.g. sample management, batch release, stability, lab execution). Act as a SME in one of the following areas: QA, QC Lab or Stability. Assist sites during data discovery to identify the scope and the master data elements that need to be created as part of the LabVantage deployment. Triage site change request, evaluate feasibility and global impact. Prioritize requests according to site needs. Work with the project manager to identify and report key process indicators to report the progress of site deployments. Collaborate and manage third-party partners to successfully deploy LabVantage. Work with the Global LabVantage team to ensure that the process designed in LabVantage are compliant with data integrity and GMP requirements. Understand local requirements and apply them to standardized global business processes. Communicate new and changed business processes to sites and influence the sites to adopt these globally standardized processes and global tools to support the site's intended use of LabVantage. Provide ongoing support and issue resolution related to business processes in LabVantage. Involve Tech@Lilly for system related issues. Identify software gaps and/or business processes changes that must be created to support site deployment. Raises issues to the Site Council and or LabVantage leadership team. Share key learning and standard practices to increase their system knowledge, and identify transferable work processes between sites. Provide answers to questions from inspections, audits, and other formal and informal assessments that impact globally owned applications and their Specialised workflows. Support system releases by implementing UAT and updating impacted procedures. Act as an extended master data support when required by the master data workstream. Minimum Requirements:
Bachelor's degree Minimum 3 years of laboratory experience Education Preference:
Bachelor's degree in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related field. Skills:
Experience working in/with GMP laboratories Strong scientific background Clear understanding of quality laboratory issues and activities Experience in defining and improving business processes Knowledge of cGMP and quality systems Solid understanding of GMP requirements and data integrity principles. Proven work with computer systems and their adaptability to existing business processes. Extensive knowledge of analytical methods, laboratory documentation and control processes. Knowledge of product release processes. Experience managing stability program. Ability to manage multiple priorities simultaneously. Additional Information:
This position will require occasional travel to manufacturing sites, development laboratories, and application vendors. Individuals must be willing to visit laboratory and manufacturing sites involving unique PPE and/or gowning requirements. This role is primarily on-site, with the flexibility to work from home four days a month. Location posted as Indianapolis but open to other locations where Lilly has a manufacturing site. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. 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. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $162,800. 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.