Job Information
Lilly Analyst - QC Microbiology in Durham, North Carolina
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.
Position Description
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 Microbiologist/biologist performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines.
Overall Responsibilities
Performs accurate and timely testing of routine and non-routine lab samples in accordance with appropriate GMP and safety guidelines.
Responsible for performing data review activities within the department, as required.
Participates in and documents laboratory investigations as well as deviation investigations.
Required to provide support or assistance with equipment qualifications, method transfers/verifications, continuous improvement initiatives as well as document authorship activities.
Shares technical information and best practices within department and with cross-functional teams.
Provides training support for the team (sterility, bioburden, endotoxin, TOC, Conductivity, particulate matter, etc.).
Requirements
Bachelors Degree in Biology, Microbiology, or related science
Previous Experience in GMP Micro Lab
Preferences
Teamwork and interpersonal skills
Strong verbal and written communication skills
Understanding of compliance requirements and regulatory expectations
Knowledge and experience with laboratory testing techniques practices in support of testing for Endotoxin, Bioburden, Sterility, Identification techniques, TOC, Conductivity, Nitrates, Growth Promotion and Biological Indicator testing. Also, an understanding of aseptic techniques, environmental monitoring, and utilities monitoring.
Ability to focus on continuous improvement.
Effective time management
Effective problem-solving skills
Tasks may require repetitive motion (e.g., keyboarding).
Technical writing and written communication skills are a plus.
Other Information
Minimal travel required.
Flexible schedule and available to work weekends and overtime.
Ability to work in various areas within the site. Some allergens are present in the parenteral plant.
Minimal travel required
Post Offer testing exam may be required.
Must pass a vision exam and be free of color blindness
Must be equivalent to 20/20 correctable close vision acuity
Job Level depends on experience.
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