Sr. Infrastructure Scientist – QC Lab Systems

Location: Indianapolis

Sr. Infrastructure Scientist – QC Lab Systems page is loaded## Sr. Infrastructure Scientist – QC Lab Systems locations:
US, Indianapolis INtime type:
Full time posted on:
Posted Todayjob requisition :
R-101232

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.

Help deliver and shape the future of the lab and its constituent talent within the Parenteral Quality Control organization! The IPM QC Sr. Infrastructure Scientist (or Principal to Sr. Principal Scientist), will join the IPM Quality Control Organization and be part of the Lab Infrastructure Team.

The candidate will be responsible for monitoring laboratory performance to ensure QC laboratory maintains a state of control regarding the generation and reporting of analytical data. Responsibilities include monitoring, execution, maintenance, and continuous improvement of the Laboratory Quality Systems (LQS) for Parenteral QC and serving as a business SME for laboratory IT systems. The candidate would be responsible for mentoring / educating other lab analysts on quality / lab systems, managing audit activities and for oversight for Management review, Laboratory metrics, and laboratory documentation.
** Key Objectives / Deliverables:
*** Collect and report metrics related to quality process.
* Act as business representative and contact SME for laboratory systems e.g., Quality Docs, Trackwise, Empower, Darwin, Smart Lab, Balance scorecard.
* Lead site deployment and upgrades of QC laboratory systems such as Darwin, Empower, Smart Lab, Lab Vantage.
* Responsible for data gathering and authoring of management review document for the Laboratory Quality system.
* Apply knowledge of quality principles, Laboratory Systems, and cGMPs towards the development and execution of local procedures, training courses (OJTs), and practices.
* Participate in identification and implementation of Continuous Improvement initiatives.
* Coordinate creation / revision / archiving of laboratory documents.
* Manage and support Audit and Inspection activities for the QC laboratory.
* Responsible for technical oversight for development and management of laboratory methods and equipment. Troubleshoot equipment and methods as required.
* Write protocols for non-routine testing or validation with appropriate guidance.
* Recognizes when a deviation from procedures, etc. has occurred and initiates and participates in a Root Cause Investigation. Share technical information and best practice within plant sites or group.
* Owner of complex moderate/major deviations and mentor on change controls, analytical investigations, investigations for deviations, and activity planning as needed
* Verify (SPV) analytical data of other analysts within the lab as requested.
* Comply with and implement safety standards.
*
* Minimum Requirements:

*** Bachelor (4-year college) degree in a science field related to the lab in which they are placed (e.g., chemistry for chem labs or micro or biology for micro or pharma lab).
* Minimum 3 years of demonstrated relevant experience in a GMP (analytical chemistry, microbiology, or biology) Quality Control lab.
* * Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
*** Additional Preferences:**
* ** Proficiency with computer systems including Microsoft Office products, LIMS, Lab Vantage, Smartlab, Darwin, and MODA preferred.
*** Knowledge and experience with Aseptic Techniques and EM / Micro QC Labs.
* Ability to work in a lab environment including wearing appropriate…