Quality Assurance (QA) Specialist - QC Support

The Indianapolis Parenteral QA for QC Representative provides daily oversight, assistance, and guidance to laboratory issues such as non‑conformance investigations, change control proposals, procedure/master formula revisions, validations, batch disposition, commissioning, and qualification activities. They advise and support other QA for QC Representatives and are essential for maintaining GMP compliance and preparing for regulatory inspections. Key Objectives / Deliverables Adhere to safety rules and maintain a safe work environment by supporting HSE corporate and site goals. Lead, mentor, and coach laboratory and support personnel on quality matters. Ensure regular presence in laboratory areas to monitor GMP programs and quality systems. Participate in local process team activities and provide project support. Assess and triage deviations/observations 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. Effectively review and/or redline documents to ensure quality attributes are met. Participate in Lean Projects to 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, and validation documents for computer systems and equipment to ensure compliance. Network with Global Parenteral Network sites as resources and benchmarking sources. Minimum Requirements Bachelor’s or equivalent (Science or Engineering related degree preferred). 1+ year of experience in a GMP facility. Additional Preferences Demonstrated experience in a GMP facility. Strong oral and written communication and interpersonal skills. Demonstrated decision making and problem solving skills. Knowledge and understanding of manufacturing process and Quality Systems. Technical writing and communication skills. 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 Lilly Event and Change Management processes. Proficiency with computer systems including Microsoft Office products, Regulus, TrackWise, PMX, and SAP. Additional 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; mobility requirements and exposure to allergens should be considered. Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role. EEO Statement 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. Compensation and Benefits The anticipated wage for this position is $65,250 - $169,400. Full‑time employees may be eligible for a company bonus. Lilly offers a comprehensive benefits program including 401(k) participation, pension, vacation benefits, medical/dental/vision coverage, flexible benefits, life insurance, leave of absence, and well‑being benefits. #J-18808-Ljbffr