<p>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.</p> <p>The PR&D Quality Assurance Analytical Primary Loop Representative ensures continued organizational alignment with the business strategy and that laboratory activities conducted by PR&D and Collaboration Partners (CPs) are carried out in accordance with PR&D quality standards and/or are following current Good Manufacturing Practice (cGMP). This role is responsible for assuring the laboratory maintains a state of control with regards to the generation and reporting of analytical data. Primary loop responsibilities for the oversight of analytical data generated to support GMP operations for PR&D are required.</p> <p>Key Responsibilities</p> <p>1) Provide QA oversight for PR&D, PR&D CPs and PR&D GMP Service Providers as required.</p> <p>2) Provide quality oversight commiserate with primary loop responsibilities, namely molecule support (internal and external testing labs), analytical equipment support, audit support, periodic lab walkthroughs, and quality assessments of quality documentations (e.g., TW1000 records)</p> <p>3) Ensure that appropriate Quality Systems are in place and are being utilized. Facilitate quality improvement initiatives, and the implementation of new quality standards.</p> <p>4) When necessary, evaluate potential impact of incidents on the quality of materials, or the integrity of data.</p> <p>5) Ensure appropriate investigations are conducted for deviations, stability failures and out of specification (OOS) results. Review and approval of the corresponding documentation.</p> <p>6) Perform Quality Assurance review and/or approval /rejection of GMP documentation and ensure that review/approval by appropriate technical experts has occurred.</p> <p>7) Be available for consultation on quality-related issues as needed.</p> <p>8) Provide quality oversight to ensure compliance with internal standards and applicable regulations by maintaining a regular presence in PR&D areas and performing internal audits as scheduled.</p> <p>Basic Qualifications:</p> <ul> <li> <p>Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or Engineering, or equivalent experience.</p> </li><li> <p>Minimum 2 years of quality experience, (pharmaceutical experience preferred)</p> </li></ul> <p>Additional Skills/Preferences:</p> <ul> <li>Experience in Quality Assurance/Control, Technical Services, Laboratory, Development, or Manufacturing desirable. </li></ul> <p>Additional Info:</p> <ul> <li> <p>This position is based in Indianapolis, IN and requires onsite presence the majority of the time (not remote).</p> </li><li> <p>Business title may vary depending on leveling.</p> </li></ul> <p>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.</p> <p>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.</p> <p>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.</p> <p>Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is</p> <p>$63,000 - $162,800</p> <p>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.</p> <p>#WeAreLilly</p>