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.
Responsibilities: 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
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$18.02 - $34.90
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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