Lilly Quality Assurance Specialist (Corporate Engineering) in Indianapolis, Indiana
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 35,000 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.
QA for Corporate Engineering Quality Systems provides a variety of global support to the Global Engineering network. The role provides quality support and oversight to the corporate engineering quality system including Global Facilities Delivery, Engineering Technical Center, and some elements of Global Packaging and Robotics. The QA person will work across the corporate engineering functions to implement requirements from applicable standards (e.g., EFS, GQS, LQS) and drive quality improvements where warranted.
Provide oversight for Corporate Engineering (CE) quality system execution.
Approve CE local procedures that impact quality and other CE documents that require quality signature
Perform site self-assessment
Create deviations, change controls, action items, quality plan
Ensure requirements are reflected in functional CE procedures
Review proposed changes to engineering and quality standards as needed
Review Best practices and master specs
Own and execute the supplier/ service provider quality management for corporate engineering
Perform computer system quality responsibilities for systems owned by corporate engineering
Provide Quality support to the Global Facilities Delivery (GFD) organization, including Quality oversight of the GFD operations and GFD projects
Partner with Engineering / Automation to interpret/ implement requirements
Bachelor's Degree in Engineering or equivalent.
Strong knowledge of CGMP and quality systems with a minimum of 10 years of direct CGMP experience.
Direct experience with FUME quality systems (e.g., qualification, maintenance, utilities)
Additional Skills/ Preferences
Demonstrated ability to interpret and apply standards to different situations.
Demonstrated ability to communicate and deliver constructive feedback to customers, including good oral, written, and presentation skills.
Ability to travel.
Able to attend training courses, conferences or association meetings and share information with other members of the group and drive needed changes.
Computer system quality training and/or equivalent experience.
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at firstname.lastname@example.org.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!