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.

Scope

Responsibilities will include to provide support to a 24/7 manufacturing operations, maintain Quality Systems, Compliance, and Good Manufacturing Practices (GMP) compliance. The Principal Associate for Quality Assurance provides proficient assistance and guidance in deviation investigations, analytical investigations, change control proposals, procedures and master formula revisions, process and equipment qualification, validation, and batch disposition.

Main Responsibilities

Support production floor operations to a 24/7 manufacturing operations (on-site support).Batch production records review/approval and performing batch disposition.Review and approve investigations, as appropriate, assuring robustness of Root Cause Analysis and effectiveness of CAPA’s.Provide guidance to manufacturing personnel related to data integrity management and quality systemsEffectively write, review and/or approve technical and quality documents to ensure quality attributes are metProvide guidance to manufacturing personnel related to regulations (BLA CFR 600 series prefer)Support and participe in Regulatory inspectionsDemonstrate proficiency in Cleaning Processes, Cleaning Validation, Process Qualification, Equipment Qualification, Process Validation, Contamination Control, Environmental Control of Clean Rooms, Method Validation.Demonstrate proficiency in Risk Assessment and FMEAs.Active participation in Gemba Walks, manufacturing rooms inspections, and practice matches procedure on the production floor.Serve as a liaison between the Process Team and other Quality areas (Labs, Compliance, Incoming, Engineering, Automation, Technical Services, Utilities, etc.)Demonstrate proficiency to interpret and apply standards to different scenarios

Basic Requirements

Minimum of Bachelor of Science (Chemical Engineering, Biochemistry or Biotechnology.) Most preferable a Licensed Doctor of Pharmacy (Pharm D).At least five (5) years of experience in Quality Assurance supporting Manufacturing, Compliance/Audit, Quality Systems, QA for Quality Control, and/or Technical Services/Manufacturing Science.

Other Skills & Preferences

Bilingual (Spanish & English)Strong written and verbal communication skills.Demonstrate teamwork by collaborating cross functionally with various levels of the organization. Communication skills with personnel at different organizational levels.Organize and prioritize multi-functional tasks. Attention to details and ability to identify improvement opportunities or discrepancies. Work well and make logical decisions under fast-paced work environment.Exercise sound judgment and be assertive when required. Work under minimal supervisionDemonstrated decision-making, problem-solving, organizational, and critical thinking techniques. Ability to share knowledge and train others. Strong compliance mindset.Knowledge on pharmaceutical / biotechnology operations and its related sciences.Managing multiple project objectives.Technical Writing.Root Cause Tools and Investigation WritingKnowledge of Current Good Manufacturing Practices (cGMPs).Computer literate.

Availability

Must be available to provide support to a 24/7 manufacturing operationsWork and provide support during irregular hours, shifts rotation, weekends, and holidays, when required.Availability and flexibility to work extended hours when required.Availability to work as a resource in other strategic areas of Quality Assurance, QA for Quality Control, Compliance based on business needs.

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

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

$51,000 - $115,500

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.

#WeAreLilly