API Manufacturing Quality Specialist

2 months ago

Lebanon, Pennsylvania, United States Lilly Full time
Job Summary

We are seeking a highly skilled Quality Assurance Associate to join our team at Lilly. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our API (Active Pharmaceutical Ingredient) small molecule manufacturing operations.

Key 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.
  • Coordinate and perform 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.
  • Ensure all processes are in an appropriate state of control.
  • Evaluate and ensure compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams to resolve quality-related issues.
  • Develop and implement quality improvement initiatives.
  • Participate in regulatory inspections and audits.
  • Stay up-to-date with industry trends and regulatory changes.
Requirements
  • Bachelor's Degree in a relevant field, such as Engineering, Chemistry, Biology, or a science-related degree.
  • 5+ years of experience in a pharmaceutical manufacturing environment.
  • Knowledge and/or experience in API or finished product manufacturing, QC, QA, or Engineering.
  • 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.
What We Offer

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.

We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.

We are committed to diversity and inclusion and strive to create a workplace that is welcoming and inclusive for all employees.

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