Quality Assurance Specialist (Corporate Engineering)
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.
Job Description
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 role will work across the corporate engineering functions to implement requirements from applicable quality standards and drive quality improvements where warranted. The role will also be responsible for the Quality Maintenance Standard (GQS215).
Job Responsibilities:
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-assessments.
Create deviations, change controls, and quality plan action items.
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.
Provide Standard ownership for GQS215 Maintenance
Basic Qualifications
Bachelor's Degree in Engineering or Science related degree.
Strong knowledge of CGMP and quality systems with a minimum of 10 years of direct CGMP experience.
3 or more years of experience in Quality Assurance.
Direct experience with FUME quality systems (e.g., qualification, maintenance, utilities).
Additional Skills/ Preferences
Computer system quality training and/or equivalent experience.
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.
Able to attend training courses, conferences or association meetings and share information with other members of the group and drive needed changes.
Additional Information
The role requires on-site presence at least 3 days per week.
Up to 10 percent US and international travel is required.
Requires visits to manufacturing sites and supplier sites.
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