Sr. Associate/principal - QA (floor Support)

QA Representative

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 are looking for people who are determined to make life better for people around the world.

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 we also develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description

The QA Representative for the Chemical Dispensing team provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure/master formula revisions, validations, batch disposition, commissioning, and qualification activities. Advise and provide support for other floor support QA Representatives. The QA Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies.

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
• Lead, mentor, and coach operations and support personnel on quality matters
• Ensure regular presence in operational areas to monitor GMP programs and quality systems
• Active on local process team, as outlined in MSOE standard, or indirect participation through project support activities
• Ability to assess and triage deviations/observations that occur within the local process team
• Work with Lilly support groups and external partners to resolve or provide advice on product related issues
• Participate in self-led inspections and provide support during internal/external regulatory inspections
• Ability to effectively review and/or redline documents to ensure quality attributes are met (i.e., deviations/observations, procedures, technical studies, validation protocols, change controls, and engineering documents)
• Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization
• Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function
• Approve commissioning qualification/validation documents for computer systems and equipment to ensure compliance with quality standards
• Network with Global Parenteral Network sites as resources and benchmarking sources as applicable flexibility within job assignment

Basic Requirements

• Bachelors Degree in a scientific field, or similar
• 3+ years of manufacturing experience, floor support experience preferred
• At least 1 year supporting quality

Additional Preferences

• Proven ability to work independently or as part of a team to resolve an issue
• Strong attention to detail
• Experience in GMP production environments or QCL is desirable
• Previous experience with Deviation and Change Management processes
• Proficiency with computer systems including Microsoft Office products, Regulus, TrackWise, PMX, and SAP
• Demonstrate strong oral and written communication and interpersonal skills
• Demonstrated decision making and problem solving skills
• Demonstrate technical writing and communication skills

Other Information

May be required to respond to operational issues outside of core business hours/days. Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

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 for further assistance.

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 $63,000 - $140,800. 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.