Lilly QC Lab Analyst - Chemistry and Devices in United States
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 35,000 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.
Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do.
Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory assures patients worldwide of safe and efficacious drug and device products, through effective execution of product testing.
A laboratory Chemistry and Device Testing Analyst performs accurate and timely testing of routine lab samples in accordance with appropriate GMP and safety guidelines, to support site production and stability requirements. The Analyst will perform laboratory testing techniques including but not limited to UV-VIS, HPLC, Capillary Electrophoresis (CE), device testing and perform compendial analysis (for example: pH, Color, Clarity, Osmolality). The Analyst will review and interpret results, and will perform second person verification (SPV) of analytical data. The Analyst utilizes technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and assist in resolving laboratory investigations of atypical data and results.
Accurately and safely perform analytical test methods or related support activities as per procedures or protocols.
Accurately record data in reports or LIMS in accordance with laboratory procedures, standards, and GMP requirements.
Recognizes deviations from procedures, methods, etc. and initiates an investigation as required.
Verify (SPV) analytical data generated by other analysts within the lab as required.
Adhere to all Environmental, Health, and Safety standards.
Identify and communicate opportunities for improvement initiatives in daily work activities.
Troubleshoot equipment and methods as required.
Support lean lab and 5S initiatives.
Understand the scientific principles required for testing of drug substances and drug product, including the interaction of the chemistry and lab equipment.
Provide technical support for non-routine (e.g., deviation) investigations.
Maintain inventory of all supplies and consumables for the laboratory.
Requirements (Education, Experience, Training):
- Bachelor (4-year college) degree in Chemistry or Biology and relevant experience in a chemistry lab (including undergraduate research experience).
Experience with a LIMS (Laboratory Information Management System) system and Empower.
Laboratory experience with HPLC and CE instruments.
Demonstrated problem solving and analytical thinking skills.
Understanding of statistical tools and analysis.
Excellent interpersonal skills and networking skills.
Experience in a GMP QC lab environment.
Demonstrated written and verbal communications skills.
Strong attention to detail.
Ability to organize and prioritize multiple tasks.
Experience with lean lab and 5S concept.
Experience with Root Cause Analysis.
May be required to provide on call support.
Demonstrated ability to work both independently and as a part of a Team.
8-hour days – Monday through Friday.
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.
Tasks may require repetitive motion (e.g., keyboarding).
Minimal travel required.
Lilly is an EEO/Affirmative Action Employer and 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at email@example.com.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!