Eli Lilly

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 Quality Assurance Floor Supervisor is responsible for providing leadership to a team of QA Specialists, while reporting directly to the Associate Director – DAP and Warehouse Quality. The Quality Assurance Floor Supervisor provides support and QA oversight to night shift GMP operations in the Device Assembly and Packaging (DAP) area. The QA Floor Supervisor works along with their team members to support multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensure compliance

Key Objectives/Deliverables:

• 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.
• Responsible for ensuring team is trained and training remains in compliance.
• Communicates with day shift QA Floor Support Supervisor and Quality Representatives on quality and operational issues. Escalates issues to Associate Director – DAP and Warehouse QA, when necessary.
• 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, while driving the site Quality culture.
• Ensures regular presence in device assembly and packaging areas to monitor GMP programs and quality systems during night shift operations.
• Ability to assess, create, and triage deviations / observations that occur within the device assembly and packaging areas.
• Reviews and approves GMP documentation in support of daily operations such as: Return to Service and Release of equipment, product, and area holds, Spare parts consultation, Work order assessments and issue resolution, Other documents as required
• Troubleshoot and provide QA systems support to reconcile issues in multiple systems (i.e., SAP, PMX. TrackWise, GMARS)
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Effectively review and / or redline to ensure quality attributes are met.(i.e., deviations / observations, procedures, production records, validation protocols, change controls, and engineering documents).
• Ability to work cross functionally and work collaboratively with all levels of the organization.

Basic Requirements:

• High School Diploma or equivalent
• 5 years of experience supporting pharmaceutical operations

Additional Preferences:

• Ability to work night shift.
• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
• Demonstrated strong oral and written communication and interpersonal skills.
• Demonstrated decision making and problem-solving skills.
• Demonstrated knowledge and understanding of manufacturing process and Quality Systems.
• Proficiency with inventory management systems and deviations systems, (i.e. SAP, Trackwise, etc.)
• Strong attention to detail
• Proven ability to work independently or as part of a team to resolve issues.
• Ability to work overtime, as requested
• Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
• Previous experience in GMP production environments.
• Previous facility or area start up experience.
• Knowledge of Validation / Qualification activities.

Other Information:

• This position is a 12-hour 2-2-3 night shift schedule. During the project and onboarding phase, role will work eight (8) hours Monday-Friday day shift, then transition to night shift schedule.
• May be required to respond to operational issues outside of core business hours / days.
• Occasional overtime work may be required.
• Applicant may work in various areas within the DAP and Warehouse buildings. Mobility requirements should be considered when applying for this position.
• Position is night shift (6pm to 2am), but occasional first shift work may be required.
• Position may require a short duration assignment of 1-3 months in Indianapolis to establish specific device knowledge and establish global contacts.

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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