Informatics Specialist

Biopharma Careers; Concord (NH); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly is seeking a QC Laboratory Informatics Specialist to support laboratory operations by ensuring electronic systems function per intended use and regulatory requirements. The role interacts with global and local IT teams to configure systems like LabVantage LIMS, Empower, MODA, NuGenesis ELN and SDMS, and to monitor data integrity.

The ideal candidate holds a Bachelor's in a science field, has IT systems experience in GMP labs, and is authorized to work in the United States.

Qualifications

• Bachelor’s degree in a computer science, life science, or applied science field.
• IT systems experience (installation and qualification of laboratory IT systems, population of master data, and configuration of systems).
• Minimum 3 years experience in a GMP laboratory.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• 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, NuGenesis ELN and SDMS.
• Ensures data integrity by design within the QC laboratory.

Skills

IT systems experience

GMP laboratory experience

Data integrity focus

Regulatory compliance

Education

Bachelor’s degree in computer science / life sciences / applied sciences

Master’s degree (preferred)

Tools

LabVantage LIMS

Empower

MODA

NuGenesis ELN

SDMS

Laboratory Execution Systems

MS Office

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The QC Laboratory Informatics Specialist 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, NuGenesis ELN and SDMS, 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, NuGenesis ELN and SDMS.
• 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.
• Performs non-terminal record monitoring activities.
• Supports audit trail discrepancies if found during system audit trail review.
• 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 field.
• IT systems experience (installation and qualification of laboratory IT systems, population of master data, and configuration of systems).
• Minimum 3 years experience in a GMP laboratory.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Skills/ Preferences

• Master’s degree
• Proficiency with computer systems including Microsoft Office products, LabVantage 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.
• Experience with master data management activities including specifications, test methods, sample plans, and product configurations within LabVantage
• Experience with performing data migrations and master data transfers across environments (DEV/TEST or STAGE/PROD)
• 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.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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.

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