Qc Laboratory Data Reviewer

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.

Company Overview:

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

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.
Responsibilities:
A QC Laboratory Data Reviewer performs accurate and timely review of laboratory data, in accordance with appropriate GMP and safety guidelines, to support site production and stability requirements. The QC Laboratory Data Reviewer will perform data review for laboratory test results including but not limited to UV-VIS, HPLC, Capillary Electrophoresis (CE), device testing and compendial analysis (for example: pH, Color, Clarity, Osmolality). The QC Laboratory Data Reviewer will also support initiating change controls and authoring investigations for the QC laboratory. The QC Laboratory Data Reviewer 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. The QC Laboratory Data Reviewer may also be required to perform Chemistry and device testing at times to support business needs. Testing would include, but not be limited to HPLC, UV-Vis, Capillary Electrophoresis, device testing, compendia testing.

Key Objectives and Deliverables

• Provide technical support for non-routine (e.g., deviation) investigations.
• Review analytical data generated by other analysts within the lab as required.
• Recommend CAPAs for laboratory investigations.
• Recognizes deviations from procedures, methods, etc., and initiates investigations as required.
• Strong understanding of FDA guidelines, Compendial and cGMP requirements.
• Adhere to all Environmental, Health, and Safety standards.
• Understand the scientific principles required for testing of drug substances and drug product, including the interaction of the chemistry and lab equipment.

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

• Demonstrated ability to work both independently and as a part of a Team.
• Experience with a LIMS (Laboratory Information Management System) system and Empower.
• Demonstrated problem solving and analytical thinking skills.
• Demonstrated written and verbal communications skills.
• Previous experience testing by compendia methods.
• Excellent interpersonal skills and networking skills.
• May be required to provide on call support.
• Strong self-management and organizational skills.
• Understanding of statistical tools and trend analysis.
• Laboratory experience with HPLC and CE instruments and Testing.
• Ability to organize and prioritize multiple tasks.
• Experience in a GMP QC lab environment.
• Strong attention to detail.
• Experience with Root Cause Analysis (fishbone, 5 why’s, Casual Factor, Fault Tree analysis).
• Trackwise experience (change controls, Investigations, Activity Planning).

Additional Information:

• Tasks may require repetitive motion (e.g., keyboarding).
• 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.
• 8-hour days – Monday through Friday.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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