The QC Lab Technician, Device Quality, is primarily responsible for providing technical support and expertise for work processes and activities associated with laboratory operations, performing testing in support of commercial and development product, and supporting laboratory investigations.
Develop and maintain knowledge of applicable regulations, LQS, and GQS requirements in order to network and influence Lilly's and the industry's application.
Implement, maintain, and/or enhance appropriate quality systems within IDM QC laboratory.
Provide Quality Control support for the IDM QC laboratory.
Author, maintain, and instruct on OJT courses for laboratory equipment, testing inspection, and laboratory operations.
Perform and oversee QC laboratory equipment setup, operation, and maintenance.
Build and maintain working relationships with DDR&D, TS/MS, Lilly final Device Assembly/ Packaging Sites, and Contract Manufacturers supporting batch release testing of Lilly product.
Participate in new product design and pre-launch preparation projects to support laboratory operations and device testing.
Participate in departmental process improvement activities.
Maintain IDM QC laboratory inventory management.
Assist in equipment qualification testing activities including IQ, OQ, and PQ.
Maintain and manage the reference sample retention area.
Support and perform laboratory device testing for commercial and development product using good documenation practices.
Perform test equipment setup, operation, and maintenance.
Support shipping and receiving activities as assigned.
Create/Edit lot release workshops as needed.
Maintain laboratory notebooks, including authoring, revision, and retirement
Participate in regulatory agency and internal inspections.
Ensure that all test equipment is properly validated and maintained for its intented use.
Support Event Management through roles of originator and executor of deviations impacting the QC laboratory, including origination of SARE as appropriate.
Support Change Management through roles of originator and/or executor of tasks and implementation steps.
Basic Requirements:
High school diploma or GED required, with some post-secondary education or associates degree preferred
Minimum of 2 years of regulated industry experience with demonstrated knowledge of related quality systems and regulatory requirements (e.g., cGMP, 21CFR820, ISO 13485, ISO 194971, Canadian MDR, EU Medical Device Directive, JPAL)
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Skills/Preferences:
Three years experience in Quality or TS/MS support
Strong problem solving and analytical thinking skills
Experience with Parenteral products, dry products, or devices
Experience with Veeva and TrackWise
Strong verbal and written communication skills in English
Self-management / motivated
Experience in Outlook, Windows, and Microsoft applications
Excellent teamwork and ability to multi-task.
Strong curiosity skills with the ability to question/identify issues and work to resolution
Strong critical thinking/problem solving skills with an ability to apply rationale
Attention to detail
Ability to mentor/train others - share learning.
Additional Information:
Travel 10% - Limited travel may be required for OUS and domestic travel
This position is day shift. Occasional after-hours and holiday coverage may be required
This position is located at LTC-North in the IDM QC Lab
The job responsibilities of this position support the technical ladder process
Benefits
Health insuranceVision insurance
Additional Information
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.
Organization Overview:
Indianapolis Device Manufacturing (IDM) is responsible for the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly's portfolio. This includes the development and delivery of test systems and test methods in support of design verification, production, and complaint handling.
Eli Lilly · Indianapolis IN