Analyst, QC Microbiology
: Job Details :

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 Description

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 Concord 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 Microbiology 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 Bioburden Membrane Filtration, Endotoxin (RFC Method), Sterility, Growth Promotion, Particulates, Container Closure Integrity (CCI) and Microbial Identification. 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.

Key Objectives/Deliverables:

• Accurately and safely perform timely testing of routine and non-routine lab samples in accordance with appropriate GMP and safety guidelines.
• 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.
• 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 GMP microbiology lab (including undergraduate research experience).

Additional Preferences:

• Experience with a LIMS (Laboratory Information Management System) system and MODA.
• Experience performing Bioburden, Endotoxin (chromogenic, turbidimetric methods), Sterility, Growth Promotion, Biological Indicator testing, Container Closure Integrity, and Identification Techniques.
• 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.
• Demonstrated ability to work both independently and as a part of a Team.

Additional Information

• 8-hour days – Monday through Friday with flexibility to support weekends and/or overtime as needed.
• 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.

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 ( ...@lists.lilly.com ) 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.

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