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.
Job Overview:
The QA - API provides support to all quality activities including batch disposition of API batches at Contract Manufacturing organizations (CMs). The QA - API's position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.
Responsibilities:
Key Objectives/Deliverables:
Serve as a liaison between CMs and Lilly.
Provide quality oversight and be the initial contact for quality-related issues.
Escalate quality issues to Lilly QA management.
Assist in establishing and revising Quality Agreements.
Ensure compliance with Quality Agreements and MRDs.
Coordinate and perform QA responsibilities for API shipments.
Support regulatory inspection preparations and provide on-site support.
Evaluate and disposition API batches.
Ensure completion of documented checks for Certificates of Testing, Environmental Monitoring, deviations, changes, and batch documentation before batch release.
Provide quality support with a focus on holistic review of manufacturing processes.
Maintain awareness of external regulatory findings affecting product quality.
Review and approve documents such as procedures, production records, change control proposals, deviations, equipment qualifications, analytical methods, and system validations.
Participate in APR activities.
Review control chart data and the impact of deviations and changes to ensure process control.
Participate in Post Launch Optimization Teams (PLOT).
Basic Requirements:
Bachelor's of Science in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
5+ years' experience of QA API or Drug Product commercial manufacturing
Additional Skills/Preferences:
Thorough technical understanding of quality systems, regulatory requirements and Commercial GMP
Knowledge of pharmaceutical manufacturing operations.
Demonstrated coaching and mentoring skills.
Experience in root cause analysis.
Demonstrated application of statistical skills.
Demonstrated strong written and verbal communications skills.
Strong attention to detail.
Proficiency with computer system applications.
Excellent interpersonal skills and networking skills.
Ability to organize and prioritize multiple tasks.
Ability to influence diverse groups and manage relationships.
Additional Information:
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 ( ) 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
$63,000 - $162,800
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.