Supervisor - Quality Assurance Floor Support (Night Shift)

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.

Organization Overview

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

The Quality Assurance Floor Support supervisor is responsible for providing leadership to a team of QA Specialists, while reporting directly to the Associate Director – QA Parenteral. The Quality Assurance Floor Support Supervisor provides support and QA oversight to GMP operations in the formulation, filling and visual inspection process areas.  The QA Floor Support Supervisor works along with their team members supporting multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensure compliance.

Responsibilities :

• Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.
• Responsible for managing 6-10 Quality Specialists supporting parenteral operations with the specialist working across multiple shifts.
• Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
• Lead, mentor, and coach Quality Specialists, Operations, and support personnel on quality matters, such as aseptic practices, while driving the site Quality culture.
• Ensures regular presence in preparation, formulation, filling and visual inspection areas to monitor GMP programs, and quality systems.
• Lead, mentor, and coach Quality Specialists, Operations, and support personnel on quality matters, such as aseptic practices, continuous improvement, while driving the site Quality culture.
• Responsible for ensuring team is trained and training remains in compliance.
• Ability to assess, create, and triage deviations / observations that occur within the parenteral areas.
• Reviews and approves GMP documentation in support of daily operations such as : Maintenance Action Plans, Return to Service and Release of equipment, product, and area holds, spare parts consultation, work order assessments and issue resolution, and other documentation as required.
• Troubleshoot and provide QA systems support to reconcile issues in multiple systems (i.e., SAP, PMX. TrackWise, SmartLab, GMARS, and other systems as required.)
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Review and / or redline to GMP documents ensure quality attributes are met. (i.e., deviations / observations, procedures, production records, etc.).
• Communicates with Associate Director and Quality Representatives on quality and operational issues.
• Work cross functionally and collaboratively with all levels of the organization.

Basic Requirements :

Additional Skills / Preferences :

Additional Information :

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include : Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

35.33 - $58.89

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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