Quality Assurance Associate

2 months ago

Lebanon, Pennsylvania, United States Lilly Full time
Job Title: QA Principal Associate

We're seeking a highly skilled QA Principal Associate to join our team at Lilly. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and compliance of our API manufacturing operations.

Responsibilities:
  • Provide quality oversight of small molecule manufacturing operations, focusing on holistic review of key activities associated with or impacting the manufacturing processes.
  • Serve as the initial point of contact for all quality-related issues, coordinating and performing QA responsibilities of API manufacturing (small molecules).
  • Review and approve documents, including procedures, master production records, change controls, deviations, equipment qualifications, analytical methods, process validations, and computerized system validations.
  • Provide technical support for deviation investigations, including root cause analysis, countermeasure development, and implementation of actions.
  • Assess the impact of change controls and events on the product and regulatory commitments, ensuring all processes are in an appropriate state of control.
  • Evaluate and ensure that documented checks have been completed for Certificates of Testing and Certificates of Environmental Monitoring (where applicable), deviations, changes, and batch documentation that demonstrates requirements have been met prior to batch release.
  • Establish and monitor KPIs such as Right First Time (RFT), investigation timeliness, and batch release, working with Lilly support groups to resolve product-related issues.
  • Identify opportunities for and participate in continuous improvement, participating in regulatory inspection preparations with small molecule manufacturing operations.
  • Participate on the Technical Review Board, ensuring inspection readiness through compliance auditing, site self-assessments, GMP education, monitoring, establishing, and enhancing Quality systems.
Requirements:
  • Bachelor's Degree (preference for Engineering, Chemistry, Biology, or science-related degree)
  • 5+ or more years in a pharmaceutical manufacturing environment
  • Knowledge and/or experience in API or finished product manufacturing, QC, QA, or Engineering, preferred.
  • Experience in quality support for small molecule Drug Substance manufacturing.
  • 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.

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.

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