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Principal Associate QA for QC

3 months ago

Concord, North Carolina, United States Lilly Full time

At **Lilly**, we combine compassion with innovation to enhance the quality of life for individuals globally. As a leading healthcare organization based in **Indianapolis, Indiana**, we are dedicated to discovering and delivering groundbreaking medications to those in need, advancing the understanding and treatment of diseases, and giving back to communities through charitable efforts and volunteer work. Our team prioritizes excellence in all aspects of our work, with a focus on prioritizing people. We are seeking individuals who are passionate about making a positive impact on the lives of others worldwide.



Position Overview:

As **Lilly** embarks on a period of expansion, we are committed to providing innovative treatments to patients across the globe. With a substantial investment exceeding $1 billion, we are establishing a cutting-edge manufacturing facility in **Concord, North Carolina**. This state-of-the-art site will leverage the latest technologies to enhance our manufacturing capacity for injectable medications, device assembly, and packaging operations. This presents a unique and thrilling opportunity to contribute to the creation and operation of a novel facility. With a focus on sustainability, the Lilly Concord site will feature advanced equipment, integrated manufacturing systems, and eco-friendly practices. Do not miss out on this exceptional chance.



Key Responsibilities:

  • Adhere to cGMP standards, emphasizing good documentation practices, data integrity, and regulatory adherence
  • Collaborate with global quality teams to ensure consistent and compliant strategies are implemented
  • Provide leadership and guidance to laboratory staff on quality initiatives and oversee GMP programs
  • Ensure quality oversight for the validation of laboratory systems, buildings, and instrumentation
  • Review and approve documents to uphold Lilly Global Quality Standards
  • Promote a robust quality culture, fostering communication and teamwork among employees
  • Support inspection readiness efforts and conduct site self-inspections
  • Lead quality-related projects and address compliance issues promptly
  • Facilitate training for new team members and assist in deviations, change control, and documentation processes



Minimum Requirements:

  • Bachelor's degree in a scientific field or equivalent
  • 2 - 3 years of QA or QC experience in pharmaceutical manufacturing, with a focus on Microbiology



Additional Skills/Preferences:

  • Dedication to maintaining CSQA Certification
  • Prior experience in laboratory instrumentation, method transfer, and product testing
  • Demonstrated problem-solving skills and previous use of LIMS and LES systems
  • Proficiency in technical writing and familiarity with pharmaceutical regulations
  • Ability to communicate effectively with cross-functional teams
  • Strong computer skills and commitment to maintaining a safe work environment
  • Willingness to work on-site for 8-hour shifts and travel occasionally as needed
  • Eligibility to work in the United States without requiring sponsorship



**Eli Lilly and Company** and its subsidiaries are dedicated to promoting diversity and equal opportunities in the workplace. We are committed to accommodating individuals with disabilities during the recruitment process. For assistance, please contact Lilly Human Resources. This email address is solely for accommodation requests related to job applications.



**Lilly** is an equal opportunity employer and values a diverse workforce without discrimination based on various factors. Our employee resource groups offer valuable support networks and opportunities for career development, including groups such as African American Network, Women's Network, and LGBTQ + Allies, among others.