Scientist - QC Microbiology

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Job description

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.

Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description:

Relies on extensive experience and knowledge in the field of Microbiology to perform advanced level work in a compliant manner such as creating and/or revising technical documents, creating and/or leading special microbiological projects, and training new/existing employees on procedures and job functions. Uses scientific expertise to provide assistance to coworkers for troubleshooting, laboratory investigations and problems resolution. Suggests process improvements to QC management. Maintains familiarity in a variety of microbiological concepts, practices, and procedures. Conducts routine and non-routine analyses of in-process materials, final products, raw materials, environmental/water samples, finished goods, validation and stability samples by appropriate Microbiological methods as assigned by Supervisor as needed. Performs routine QC responsibilities as needed. Applies acceptable cGMP practices during execution of all work tasks. Presents innovative and creative solutions to problems. Exhibits good problem solving and technical writing skills. Updates supervisor of progress on a regular basis.

NOTE: Position is Tuesday to Saturday

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

• Performs routine QC Microbiology responsibilities as it relates to the specific job function as assigned by supervisor such as:
• Routine Water and Gas testing.
• Performs material qualifications and QC inventory control.
• Performs microbial and fungal identification.
• Performs Bioburden, Endotoxin, Sterile Hold, Total Plate Count (TPC), Sterility, Coliform and biological indicator testing.
• Prepares and maintains microbial stock culture and performs Methods suitability (bacteriostasis/fungistasis) testing.
• Assists in special projects (i.e. validations, microbiological studies, etc).
• Works weekends, overtime, and holidays as needed.
• Creates, revises, or reviews documents such as:
• SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, or invalid assays).
• Performs Excursion investigations and/or Non-Conformance Event (NCE) investigations.
• Reviews microbiology testing data and reviews of logbooks.
• Trains, leads and/or directs the work of others, as needed. Provides microbiological guidance to Technicians in his/her group. Monitors laboratory equipment for temperature and conformance to specifications.

Basic Requirements:

• BS or MS in a related science such as Biology, Biochemistry or other science discipline.

Additional preferences:

• Good working knowledge of cGMP regulations.
• Excellent teamwork and communication skills.
• Attentive to detail.
• Ability to work independently and achieve problem resolution with minimal supervision.
• Competent in use of Microsoft Office programs.
• Comfortable with computerized data storage systems (i.e. MODA, LIMs, TrackWise, etc).

Other Information:

• Travel not required.
• Lifting not required.
• Required to be on call.
• Shift work may apply.

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 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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