Principal Scientist QC Device

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 Scientist performs accurate and timely testing of routine lab samples in accordance with appropriate GMP and safety guidelines, to support site production and stability requirements. Completes second person verification of results for QC Device and Incoming Teams. Lead in laboratory root cause investigations, deviations, and quality system improvement initiatives by completing well-defined protocols and procedures.

Responsibilities:

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Perform routine laboratory analyses.
• Verify (SPV) analytical data.
• Participate in the transfer of analytical methods for marketed products, including authoring and reviewing method certification documentation, execution of laboratory testing, and investigation of observations.
• Perform comprehensive review of data for release of data from the laboratory.
• Initiate and author change controls, deviations, and laboratory investigations.
• Utilize technical skills to perform in-depth investigations associated with out-of-specification results and aberrant data.
• Troubleshoot equipment and methods as required.
• Assist in improvement of quality systems by creating or revising worksheets and other lab documentation systems.
• Identify and communicate opportunities for improvement initiatives in daily work activities and support Lean Lab initiatives.
• Share technical information and best practice within plant sites or group.
• Write protocols for non-routine testing or validation with appropriate guidance.

Basic Qualifications:

• Bachelor or Masters in a science or engineering discipline (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.)
• Demonstrated proficiency in laboratory analysis
• Experience in a GMP laboratory
• Ability to working in a lab environment including wearing appropriate PPE and other safety required equipment and considerations

Additional Skills/Preferences

• Experience with LabVantage LIMS
• Experience with Linear Force Test Equipment/Instrumentation
• Demonstrated written and oral communication skills and ability to collaborate and interact with management, scientists, engineering, and IT personnel
• Demonstrated problem-solving skills
• Training and experience in Root Cause Analysis Methodology

Additional Information:

• 8-hour days – Monday through Friday
• Required to be available off shift and respond to operational issues as needed
• Tasks may require repetitive motion and standing for long periods of time (e.g., keyboarding)

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

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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