Analyst QC Chemistry and Devices

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.

Organization Overview:

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.

Responsibilities:

• 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 investigations 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.

Basic Requirements:
Bachelor (4-year college) degree in Chemistry, Biology or Microbiology and Relevant experience in a chemistry lab.

Additional Skills/Preferences:

• 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 the 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.

Additional Information:

• 10-hour days – Wednesday through Saturday.
• 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 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 Employe