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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,000 - $162,800

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN.  This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products.  This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. 

Job Description:

To provide support to the Lebanon API Manufacturing Plant (LP1) materials management systems. The Materials Management (warehouse and tank farm) representative provides Quality Oversight for the inbound and outbound materials activities at the LP1 Site. This position supports all Materials Management activities relative to LP1 Inbound Products to ensure appropriate Quality Oversight.

The Materials Management (Warehouse) QA will provide assistance and guidance concerning incoming QA, warehouse QA, and incoming material disposition. This role reports directly to the Associate Director – Quality.  The Materials Management (Warehouse) QA position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies as well.   

Responsibilities:

Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.Participate in activities to involve QA Incoming, QA Warehouse/Tank Farm, and QA Incoming Batch Disposition.Responsible for Tank Farm/ Solvent Recovery activities as it relates to QASupport QA incoming functions at multiple warehouse locations and tank farm/solvent recovery.Responsible for:Performing incoming inspections (raw materials, components, printed packaging materials, etc.) according to priority.Evaluate and oversee timely release of incoming bulk solvent for Tank Farm and recovered solvent(s) from Tank Farm/Solvent Recovery unit(s).Working experience in tank farm receipt and release of materialsDocumenting inspections in accordance with procedures and specifications.Ensuring materials not meeting specifications are quarantined, per local procedures.Sampling, inspecting, and documenting results utilizing electronic systems (LIMS, etc).Working with the QC Lab to deliver samples and receive resultsPerforming ID testing of materials utilizing Raman or NIR Spectroscopy. Maintaining retains and samples per local procedures.Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.  Ensuring storage condition is tracked, accurate, adjusted (as needed) including evaluating temperature excursions on shipments received at the warehouse.Assists in resolving issues on inbound shipments (i.e. incorrect quantity or product, contamination, etc.). Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, scrapped, etc.)Disposition of incoming raw materialsProvide Quality support to warehouse with regard to deviations and other non-conformance issuesResponsible for ensuring training remains in compliance.Communicates with QA Associate Director Materials and other cross functional peers on quality issues.Mentor and coach warehouse and support personnel on quality matters, while supporting and driving the site Quality culture.Ensure regular presence in operational areas to monitor GMP programs and quality systems.Work with materials management QA group to initiate complaints/remarks to supplier for materials not meeting Lilly expectations.May participate in investigations regarding materials or service complaints.Networks with the business and ensures all materials are dispositioned in a timely manner to support production schedule.Authors/revises SOPs, materials specifications, as needed.Supports material related Supplier Change Notification's (SCN).Participates in/supports regulatory inspections, as needed.

Basic Requirements (Education, Experience, Training):

Bachelor’s Degree (Chemistry, Engineering, Pharmaceutical, or related)5+ years of QA experience in a regulated environment2+ years of experience in materials management for QA2+ years of experience in solvent recovery

Additional Preferences:

Previous emergency response and hazardous materials experienceAbility to influence externally with suppliers and resources across sitesDemonstrated understanding of cGMP regulations related to QA Inspection applications.Strong attention to detail.Proficient in computer system applications.Ability to organize and prioritize multiple tasks, highly flexible and able to work independently in fast paced environment to support production demands.Excellent interpersonal and networking skills.Highly motivated, enthusiastic, share ideas and lead solutions effectively to resolution; ensure safety of others.Understanding of statistical tools and analysis.Experience in inventory management systems (SAP, EDMS, LIMS, etc.)Previous experience in GMP production environments.Previous facility or area start up experience preferred.
 

Additional Information:

Some geo-flexibility during the first year for a short-term assignment for training purposes is preferable.

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 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.

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.

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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