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Scientist - Quality Control Laboratory Informatics
Lilly • Pleasant Prairie, WI 53158 • Posted 11 days ago
Scientist - Quality Control Laboratory Informatics
Lilly • Pleasant Prairie, WI 53158 • Posted 11 days ago
In-person • Full-time • $63,000-$162,800/yr • Mid Level
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.
**Responsibilities**
The Scientist - QC Laboratory Informatics role is responsible for supporting laboratory operations through ensuring that electronic laboratory systems function per intended purpose and use, specifically related to end user functionality and to system compliance with company and regulatory requirements. Responsibilities will initially involve interacting with global and local IT support functions to populate master data, configure systems, and assist with installing and qualifying laboratory IT systems such as LabVantage LIMS, MODA, Empower, and other laboratory systems. The role will evolve into monitoring, execution and maintenance of the Laboratory IT Systems for the QC laboratory with an emphasis on continuous improvement and a focus on data integrity. This role will serve as business representative for laboratory IT systems and will be responsible for mentoring and educating peers on the use of laboratory systems and equipment, oversight for management reviews, laboratory metrics and laboratory documentation as well as supporting internal and external audits as a laboratory IT system subject matter expert.
**Key Objectives/Deliverables:**
+ Performs and/or supports the laboratory with the validation of laboratory equipment and software systems.
+ Supports the establishment and maintenance of the validated state of software-based computerized systems in use within the laboratory.
+ Leads and/or supports site deployment and upgrades of QC laboratory IT systems such as LabVantage LIMS, Empower, MODA.
+ Ensures data integrity by design within the QC laboratory.
+ Acts as QC laboratory data integrity local representative.
+ Partners and builds relationships with Global Quality Laboratory Network, Global and Site IT team members.
+ Acts as a contact SME for QC laboratory IT systems.
+ Supports continuous improvement of quality systems as they relate to the QC laboratory.
+ Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.
+ Assists in improvement of quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other laboratory documentation systems.
+ Supports audit and inspection activities for the laboratory.
+ Implements and complies with corporate, site, and laboratory safety standards.
**Basic Qualifications**
+ Bachelor's degree in a computer science, life science, or applied science or other relevant field.
+ IT systems experience (installation and qualification of laboratory IT systems, population of master data, and configuration of systems).
+ Experience in a GMP laboratory.
+ Minimum 3 years of demonstrated relevant experience.
**Additional Skills/ Preferences**
+ Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems.
+ Experience operating or implementing laboratory IT systems including LIMS and Automated Lab Execution systems.
+ Investigation and deviation management experience.
+ Demonstrated proficiency in computer system validation.
+ Experience with compliance requirements and regulatory expectations.
+ Excellent oral and written communication skills and demonstrated through documentation and presentation skills.
+ Demonstrated accuracy and proficiency in analytical skills.
+ Ability to work in a laboratory environment including wearing appropriate PPE and other safety related equipment or considerations.
+ Previous experience with cross-function leadership utilizing problem-solving and decision-making skills.
**Additional Information**
+ Tasks may require repetitive motion and standing for long periods of time.
+ 8-hour days - Monday through Friday
+ May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.
+ Applicant will work in various areas within the site. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
+ Minimal travel required.
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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
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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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.
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
**Responsibilities**
The Scientist - QC Laboratory Informatics role is responsible for supporting laboratory operations through ensuring that electronic laboratory systems function per intended purpose and use, specifically related to end user functionality and to system compliance with company and regulatory requirements. Responsibilities will initially involve interacting with global and local IT support functions to populate master data, configure systems, and assist with installing and qualifying laboratory IT systems such as LabVantage LIMS, MODA, Empower, and other laboratory systems. The role will evolve into monitoring, execution and maintenance of the Laboratory IT Systems for the QC laboratory with an emphasis on continuous improvement and a focus on data integrity. This role will serve as business representative for laboratory IT systems and will be responsible for mentoring and educating peers on the use of laboratory systems and equipment, oversight for management reviews, laboratory metrics and laboratory documentation as well as supporting internal and external audits as a laboratory IT system subject matter expert.
**Key Objectives/Deliverables:**
+ Performs and/or supports the laboratory with the validation of laboratory equipment and software systems.
+ Supports the establishment and maintenance of the validated state of software-based computerized systems in use within the laboratory.
+ Leads and/or supports site deployment and upgrades of QC laboratory IT systems such as LabVantage LIMS, Empower, MODA.
+ Ensures data integrity by design within the QC laboratory.
+ Acts as QC laboratory data integrity local representative.
+ Partners and builds relationships with Global Quality Laboratory Network, Global and Site IT team members.
+ Acts as a contact SME for QC laboratory IT systems.
+ Supports continuous improvement of quality systems as they relate to the QC laboratory.
+ Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.
+ Assists in improvement of quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other laboratory documentation systems.
+ Supports audit and inspection activities for the laboratory.
+ Implements and complies with corporate, site, and laboratory safety standards.
**Basic Qualifications**
+ Bachelor's degree in a computer science, life science, or applied science or other relevant field.
+ IT systems experience (installation and qualification of laboratory IT systems, population of master data, and configuration of systems).
+ Experience in a GMP laboratory.
+ Minimum 3 years of demonstrated relevant experience.
**Additional Skills/ Preferences**
+ Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems.
+ Experience operating or implementing laboratory IT systems including LIMS and Automated Lab Execution systems.
+ Investigation and deviation management experience.
+ Demonstrated proficiency in computer system validation.
+ Experience with compliance requirements and regulatory expectations.
+ Excellent oral and written communication skills and demonstrated through documentation and presentation skills.
+ Demonstrated accuracy and proficiency in analytical skills.
+ Ability to work in a laboratory environment including wearing appropriate PPE and other safety related equipment or considerations.
+ Previous experience with cross-function leadership utilizing problem-solving and decision-making skills.
**Additional Information**
+ Tasks may require repetitive motion and standing for long periods of time.
+ 8-hour days - Monday through Friday
+ May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.
+ Applicant will work in various areas within the site. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
+ Minimal travel required.
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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
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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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.
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