QA Floor Rep

---

Job description

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. 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.

Responsibilities:

• Promote safety awareness

• Remain current with individual training plan

• Observe, promote, and comply with requirements related to safety, quality, security, customer service, and GMPs

• Assure proper review and approval of documents in alignment with GQS, SOPs, and Industry Practices in a timely manner

• Represent Quality on Warehouse Process Team

• Provide consultation and interpretation of quality guidance documents regarding qualification /validation, cleaning, change control, production practices, deviations, and complaint management.

• Assess Observations and Deviations in a timely manner

• Provide quality oversight of the IDAP operations and processes to support Warehouse and Logistics.

• Escalate notification to management for departures of critical nature and assure issues are addressed

• Assess gaps between local and corporate standards and facilitate remediation efforts actively working with support areas

• Ensure that area is always audit ready

• Support project timelines assuring compliance with Quality expectations

• Proactively work with areas to provide support and promote participation with Quality expectations and discuss resolution with process team members

• Possess a detailed understanding of the IDAP processes including critical parameters, components utilized, equipment, etc

• Actively participate in continuous improvements and productivity projects

• Provide quality impact assessments, reviews and approvals on validation protocols, qualification documents, change controls, deviations, holds, procedures, and maintenance work orders related to the IDAP processes

• Develop content language and assure proper review/approval of SOPs, and associated documents in Regulus

Basic Qualifications:

• Bachelor's Degree in a STEM area

• 3 years experience

Additional Skills/Preferences:

• Knowledge in cold stream, TrackWise and SAP.

• Promote Safety Awareness

• PMX and SAP experience

• Represent Quality on the Process Team especially Warehouse and Logistics.

• Assess Observations, Deviations, and Major Deviations

• Remain current with Individual Learning Plan

• Assure proper review and approval of documents in accordance with GQS, SOPs, and Industry Standards in a timely manner

• Provide Quality oversight of the IDAP operations and processes

• Provide consultation and Quality interpretation of Quality guidance documents and SOPs

• Ensure area is always inspection ready

• Proactively work across functions to provide support and promote participation in Quality initiatives

• Possess a detailed understanding of the IDAP processes

• Actively participate in continuous improvement initiatives

Additional Information:

• Nights and weekend work may be required on occasion

• Flexibility is required as work hours and start times may vary to provide coverage on shifts for specific business needs

• Applicant may work in various areas of the IDAP Plant, in which some allergens are present. Mobility requirements and exposure to allergens should be considered when applying for this position

• May be subject to a post-offer exam

• Background check may be required in order to handle Special Security Substances and Controlled Substances

• Individual must be available by cell phone

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. 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.

<!– job description page –>