Location: Concord,CA, USA
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.
Responsibilities:
Conduct investigations into manufacturing and packaging complaints for prefilled devices and combination products, conducting thorough trend analyses and preparing comprehensive reports. Collaborate with internal and external partners to drive continuous improvement initiatives while mentoring junior QA associates to enhance team capabilities.
Key Objectives/Deliverables:
* Perform complaint investigations for Concord manufacturing and packaging complaints for prefilled devices and drug/device combination products, drug/device combination products, and parenteral products.
* Support and initiate TW Trend, RCIs, Tasks or other technical investigations, as applicable
* Perform quarterly trend analysis and investigations on product and process performance
* Compile and document monthly metrics/quarterly metrics/ad-hoc reports
* Understand the devices/combination products/parenteral packaging processes to support investigations
* Collaborate and provide customer service for groups external to Concord
* Support continuous improvement projects and new launches as applicable
* Compile and present complaint data for Site Lead, Flow, and Process teams
* Complete the eAPR complaints sections for each required product including compiling/summarizing data and presentation support as necessary
* Mentor and coach other QA Associates, as applicable
Basic Qualifications:
* Minimum of three years industry experience
* Technical knowledge in design, manufacturing or validation; preferably devices
* Technical knowledge of complaint handling and/or quality systems; preferably device packaging/assembly
* Knowledge of regulatory requirements (e.g., cGMP, 21 CFR 820, ISO 13485, international standards)
* Strong computer literacy in MS Office
Additional Preferences:
* Basic knowledge in statistics and its applications
* Ability to compile data and metrics in reports understandable by management and business partners
* Attention to detail; self-management; problem solving; mentoring
Minimum Education Requirements:
* Bachelor's degree in engineering, medical, or life sciences preferred.
Other Information:
* Must be able to handle returned complaint samples requiring execution of universal precautions and medical surveillance panel.
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
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