At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
The API EM Quality Assurance Consultant provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Consultant’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.
Key Objectives/Deliverables:
- Serve as a liaison between CMs and Lilly.
- Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
- 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).
- Provide quality oversight of Lilly/APIEM Quality Plans
- Coordinate and perform QA responsibilities of API shipments from suppliers and CMs.
- Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
- Participate on the Technical Review Board
- Evaluate and disposition API batches, if required.
- 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 API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
- Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
- Ensure all processes are in an appropriate state of control.
- 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, procedures, master production records, change control proposals, deviations, 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.
Basic Requirements:
- Bachelors degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
- At least 2 years previous GMP manufacturing experience in API or Pharma experience in finished product manufacturing, QC, QA or Engineering.
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences:
- Experience in quality support for Quality Control activities
- 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.
Other Information:
- Must complete required training for API EM Quality Assurance.
- No certifications required.
- Must be able to support 24-hour/day operations.
- Continental and Intercontinental travel may occur (~20%)
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 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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400Full-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
Skills Required
- Bachelor's degree in Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
- At least 2 years GMP manufacturing experience in API or pharma finished product manufacturing, QC, QA, or Engineering.
- Authorized to work in the United States on a full-time basis; employer will not sponsor work authorization or visas.
- Complete required training for API EM Quality Assurance.
- Ability to support 24-hour/day operations.
- Experience in quality support for Quality Control activities.
- Thorough technical understanding of quality systems and regulatory requirements (cGMP).
- Knowledge of pharmaceutical manufacturing operations.
- Demonstrated coaching and mentoring skills.
- Experience in root cause analysis.
- Demonstrated application of statistical skills.
- Strong written and verbal communication skills.
- Proficiency with computer system applications and computerized system validations.
- Strong attention to detail, interpersonal and organizational skills, and ability to influence diverse groups.
Eli Lilly and Company Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Eli Lilly and Company and has not been reviewed or approved by Eli Lilly and Company.
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Retirement Support — Feedback suggests long-term savings are bolstered by a defined-benefit pension alongside a company 401(k) match and retiree health options. These elements make total compensation feel strong beyond base salary.
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Leave & Time Off Breadth — Feedback suggests paid time off is expansive, with substantial vacation, company shutdown days, and milestone time. This breadth of leave is viewed as a meaningful part of overall rewards.
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Parental & Family Support — Feedback suggests family-building and caregiving support are robust, including paid parental leave, adoption or surrogacy assistance, and backup care. These programs enhance the perceived value of benefits across life stages.
Eli Lilly and Company Insights
What We Do
Eli Lilly and Company engages in the discovery, development, manufacture, and sale of products in pharmaceutical products business segment. For more than a century, we have stayed true to a core set of values – excellence, integrity, and respect for people – that guide us in all we do: discovering medicines that meet real needs, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.
