Lilly API External Manufacturing QA for QC in Indianapolis, Indiana
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.
The API EM (external manufacturing) Quality Assurance for Quality Control provides support to all QC activities at Contract Manufacturing organizations (CMs). The QA for QC position is essential for ensuring that all QC testing is in accordance with the validated methods and are compliant to cGMPs and regulatory commitments.
Serve as a liaison between CMs and Lilly.
Provide quality oversight of Quality control activities at CMs including being the initial point of contact for all quality-related issues with testing.
Escalate quality issues at CMs to Lilly QA management.
Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
Coordinate and perform QA responsibilities of API shipments for stability testing. Provide QA oversight of API EM stability program.
Participate in regulatory inspection preparations with CMs.
Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
Provide quality support of Quality Control with the focus on holistic review of key activities associated with or impacting the quality control testing including deviations, change controls and countermeasures.
Assess the impact of analytical deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
Review and approve documents including, but not limited to, analytical procedures, change control proposals, deviations, analytical equipment qualifications, analytical methods and computerized system validations.
Participate in APR activities.
Participate in projects to improve productivity.
Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
Previous GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA or Engineering.
Thorough technical understanding of quality systems and regulatory requirements.
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.
• Travel 10%
• Indianapolis, IN
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 ( LillyRecruitingCompliance@lists.lilly.com ) 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 in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!