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.
The Senior Associate - QA Materials Management plays a critical role in supporting activities within Logistics Center operations, including goods receipt, sampling, working cell bank (WCB), kanban, VMI, kitting, weigh & dispense, drug substance put away and shipping within our next- generation manufacturing facility. This role will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
Job Responsibilities Oversee the quality assurance aspects of material receipt, material batch disposition, Re-ID or Re-eval of materials/consumables/components in accordance with GMP regulations and internal procedures.
- Support Review and collab session on change controls related to materials.
- Assess and support assessment and investigate deviations, and CAPAs related to materials, ensuring timely and effective resolution.
- Provide QA oversight and guidance during material-related investigations and problem-solving activities.
- Support the development and implementation of quality systems and continuous improvement initiatives within materials management.
- Prepare and review documentation including procedures, protocols, and reports pertaining to materials management or other key GMP documents
- Collaborate with cross-functional teams including Material operations and Supply Chain to ensure seamless material flow and compliance.
- Participate in regulatory inspections and internal audits, providing necessary documentation and support.
- Maintain up-to-date knowledge of relevant GxP regulations and industry best practices.
- Complete and support Time on The Floor activities within the area
- Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility
- Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes
- Required to be on call, as needed to support relevant areas
Job Qualifications & Skills
- Level 7 qualification or higher in Science, Engineering or related discipline.
- Minimum 3 years’ relevant experience, preferably in Quality Assurance within the pharmaceutical or biotechnology industry, with a focus on materials management.
- Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
- Proven experience with quality systems, including deviation management, CAPA, change control, and SAP.
- Strong understanding of material batch release processes.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong written and verbal communication skills with the ability to effectively interact with all levels of the organization and external stakeholders.
- Ability to work independently and as part of a team in a fast-paced environment.
- Strong experience in relevant QMS/software applications (e.g., Trackwise/Veeva, SAP (ERP & inventory Mgt systems) and automation systems e.g. MES).
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 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.
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