Scientist - Quality Control Analyst

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.

Job Summary
We are looking for a Quality Control (QC) Analyst to perform routine and advanced analytical testing, support method validation and transfers, and ensure full compliance with GMP standards. The role includes conduct investigations, maintaining accurate documentation, troubleshooting instruments, and collaborating with cross-functional teams to support continuous improvement in the QC laboratory.

Job Responsibilities

• Perform analytical testing of raw material, finished products and stability sample using validated methods using HPLC, GC, FTIR, and related techniques.
• Support method validation, method transfer and verification studies in accordance with cGMP, regulatory and internal requirements.
• Conduct OOS/OOT investigation, deviation reports, change control and CAPA to ensure data integrity and compliance.
• Support troubleshooting and maintenance of analytical instruments
• Collaborate cross-functionally with Manufacturing, QA and Development team to drive continuous improvement initiative.
• Author SOP, specifications, test methods and any other QC related documents.
• Maintain accurate documentation, reports and laboratory records in accordance with GMP standards.
• Review raw materials, finished products, stability data and technology transfer documents against approved protocols and procedures.
• Assist in monitoring changes in the monographs Pharmacopeia requirements, Regulatory agencies recommendations and implement the same in QC lab.
• Ensure the QC Laboratory is in a ready state of compliance for internal and external audit.

Job Requirements / Education/Competencies

• Bachelor of science in chemistry or related field from recognized educational institutions
• Prefers minimum of 3 years experience in a regulated environment

Additional Skills

• Possess laboratory computer skills.
• Proficient in the Microsoft Teams / Microsoft Outlook and other products.
• Excellent written and verbal English communication skills.
• Detail oriented with excellent problem solving skills.
• Operational and troubleshooting skills related to analytical instruments.
• Excellent Knowledge and understanding of GMP, GLP, data integrity.
• Proven organization and time management skills, as demonstrated through previous work and educational experience.
• Knowledge of Radio pharma is an Asset
• Must be willing to work flexible hours, including early mornings, late evening or weekend as required by project or operational needs

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. 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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

$60,000 - $140,800

Full-time equivalent employees may also 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 pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) 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.