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Principle Associate QA API External Manufacturing

Employer
Eli Lilly and Company
Location
Denver, Colorado
Start date
Mar 28, 2024

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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 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:

Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The PIP (person in plant) API EM Quality Assurance Associate will provide support to all quality activities within a dynamic external manufacturing environment. The PIP position is based in Boulder, Colorado. The candidate must be within commute distance.

The QA Associate’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. The QA Associate will need to interact daily with a wide variety of people, primarily external partners team members and site management.

Responsibilities:

  • 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.

  • Provide quality oversight of Lilly/APIEM Quality Plans

  • Coordinate and perform QA responsibilities of API shipments.

  • Participate in regulatory inspection preparations with CMs.

  • Provide on-site support during manufacturing events and 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, 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:

  • BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.

  • Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering.

Additional Preferences:

  • Experience in quality support for Drug Substance manufacturing 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.

Additional Information:

  • Must complete required training for API EM Quality Assurance.

  • No certifications required.

  • Required onsite 3 days a week and must be able to support 24 hour/day operations.

  • Some travel (<25%) is required primarily to Indianapolis, Indiana

  • Lilly currently anticipates that the base salary for this position could range from between $63,000 to $185,000 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.

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 ( Lilly_Recruiting_Compliance@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.

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.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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