Associate – Product Delivery (PD) Drug Product QA in Indianapolis

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Associate – Product Delivery (PD) Drug Product QA in Indianapolis, Apply Lilly careers in Indianapolis Indiana.


Position : Associate – Product Delivery (PD) Drug Product QA

Location : Indianapolis, Indiana

Job id: R-34135


Job Details

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 35,000 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: Product Research and Development (PRD) Quality Assurance (QA) supports the delivery of the Lilly pipeline by providing oversight of the manufacturing, packaging, and distribution of the medicines needed for clinical trials (CT).  As a QA Associate in the CT Parenteral Drug Product (DP) team, you will be responsible for Quality Oversight for the CT Parenteral Filling Facility Project and the eventual oversight of CT Parenteral DP manufacturing in Indianapolis, IN.Responsibilities: As a PD Drug Product QA Associate, you will engage cross-functionally to facilitate delivery of a new state-of-the-art parenteral CT DP filling facility.  This includes review/approval of Commissioning and Qualification (C&Q) deliverables, ensuring development of appropriate Quality System documentation and overseeing establishment of robust facility control strategies to support operational execution.  Upon facility delivery, you will provide Quality Support for the manufacture of sterile CT Parenteral Drug Products.   Additional responsibilities include, but are not limited to (there may be some crossover between the listed Facility Delivery and CT Parenteral Drug Product Production responsibilities):Facility Delivery:• Serve as a Quality contact point for Global Facilities Delivery (GFD) and provide Quality support for B358 project delivery and beyond.• Partner with QA Engineering to support the commissioning and qualification testing strategy and ensure alignment with current Good Manufacturing Practices (cGMP) and Quality System expectations.• Lead and/or contribute to various project sub-teams associated with the project.• Work with functional areas (e.g., Sterility Assurance, Technical Services, Engineering) to establish operational procedures and processes for the plant.• Influence and/or develop training materials and capability related to aseptic manufacturing and cGMPs for the organizations supporting DP manufacturing.CT Parenteral Drug Product Production:• Ensure appropriate execution of Quality Systems to ensure and sustain compliance with regulatory requirements and cGMPs.• Participate in day-to-day activities and decisions, including observation and change control processes.• Assess the impact of change controls and observations on the product and regulatory commitments.• Identify opportunities for and participate in continuous improvement (with respect to both productivity and compliance).• Qualify on visual inspection and perform associated statistical sort responsibilities.• Influence cross-functional manufacturing groups to maintain and continuously improve the quality system.• Provide support for internal and regulatory site inspections.• Partner with the existing drug product organization supporting CT Manufacturing to influence the development of internal manufacturing support capability.• Identify and escalate concerns / issues to QA and business management, as appropriateBasic Requirements:  • Minimum 2 years’ cumulative experience in Commercial or Development manufacturing in a cGMP environment, preferably in Quality Assurance• Bachelor’s Degree in science-related field (e.g., Pharmacy, Engineering, Chemistry, Biology) or equivalent work experienceAdditional Skills/Preferences:• Ability to accomplish results independently and prioritize multiple tasks• Ability to influence team interactions and lead initiatives• Previous experience in QA, Operations, TS/MS, or Engineering• Previous experience providing support to internal sterile manufacturing operations• Demonstrated problem solving skills, risk-based decision making, and learning agility• Ability to model and develop a Quality Culture cross-functionally• Root Cause Analysis / Troubleshooting skills• Demonstrated strong oral and written communication skills• Demonstrated interpersonal skills and the ability to work as part of a team• Proven ability to envision and oversee implementation of continuous improvements• Proficient with data collection/analysis systems (e.g. Power Apps, Power Automate, SQL, Python, Tableau, PowerBI, etc.)Additional Information:• Occasional travel (Domestic or International, <10%) may be required to equipment vendors, design firms, benchmarking sites or conferences.• This position will flexibly support manufacturing activities in Indianapolis (LTCN).Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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. As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).     Career Tags : Eli Lilly and Company jobs hiring in Indianapolis, Jobs nearby me in Indianapolis Indiana, Eli Lilly careers in Indianapolis Indiana, Indianapolis jobs hiring, Associate – Product Delivery (PD) Drug Product QA job nearby in Indianapolis. Note: Gulf Grip is job listing leading platform for a job seekers of worldwide, where you can find best suitable jobs for your level of interest in Indianapolis, Indiana. subscribe us on social media to have quick jobs update in Indianapolis Indiana, If you find page error  while apply Eli Lilly and Company – Associate – Product Delivery (PD) Drug Product QA  jobs in Indianapolis, you may still search job by job id – R-34135  on official career page of Eli Lilly and Company

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