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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $162,800
Job Title: QA Associate – PRD API
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). The CT Active Pharmaceutical Ingredient (API) team is responsible for the oversight of CT manufacturing executed internally within the K360 pilot plant located in Indianapolis at LTCN and at partner sites across the globe.
Responsibilities:
As the QA Associate PRD API, you will provide quality and compliance support for API manufacturing initially supporting external BRD (Bioproduct Research and Development) collaboration partners worldwide with potential long-term to support SMDD (Synthetic Molecule Design & Development) as needed based on Lilly portfolio demands.
- Support API Manufacturing, particularly as it relates to decisions associated with impact to the quality of products.
- Execute qualification and Quality oversight of API Collaboration Partner manufacturing which includes building and maintaining relationships and performing person-in-plant visits.
- Perform pre- and post- review of batch production records utilized for manufacturing.
- Author, review, approve Change Controls and Deviation investigations. Assess the impact of change controls and events on the product and regulatory commitments.
- Ensure appropriate execution of Quality Systems to sustain compliance with regulatory requirements and good manufacturing practices.
- Support and/or evaluate the disposition of batches, including management and review of GMP documentation, analytical results and regulatory commitments.
- Ensure inspection readiness through compliance auditing, site self-assessments, GMP education, monitoring, establishing and enhancing Quality systems.
- Identify opportunities for and participate in continuous improvement.
Basic Requirements:
- Bachelor’s degree in biochemistry, engineering, pharmacy, or science-related field
- At least 2 years’ experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.)
Additional Skills/Preferences:
- Previous experience supporting cGMP API/drug substance manufacturing (QA, TSMS, operations, engineering, auditing, etc.)
- Previous QA experience
- Previous experience working with external partners
- Proven ability to influence without direct authority both internally and externally.
- Demonstrated deep technical knowledge
- Experience with computer systems (i.e., TrackWise, Veeva, SAP, Excel, PowerPoint, PowerBI)
Additional Information:
- On-site, day shift position located in Indianapolis (LTCN) with expectation of 3 days per week on-site but flexibility given to the days. After hour support may be required depending on CP/business need
- Occasional travel (<10%) will be required for collaboration partner oversight, PIP, training, conferences, etc.
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 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.
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
