Associate - IAPI QA

Eli Lilly and Company • Indianapolis, IN

10d

About The Position

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 At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Brand Description The Representative – QA – IAPI provides support to Indianapolis API Operations manufacturing and laboratories and ensures quality systems and GMP compliance. The QA Representative provides assistance and guidance in deviation investigations, change control proposals, procedure and master production revisions, validations and batch dispositions. The QA Representative’s position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies.

Requirements

• BS in Engineering or a science-related field or equivalent experience.
• BSc in Engineering or science-related field or equivalent experience.

Nice To Haves

• Experience with computer system validation.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Proficiency with computer system applications.
• Knowledge of cGMPs and quality systems.
• Understanding of statistical tools and analysis.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs.

Responsibilities

• Provide direct quality oversight of production, warehouse/material management, engineering, automation and laboratory operations.
• 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.
• Provide quality guidance and recommendations with regard to manufacturing, materials, utilities, maintenance and laboratory issues.
• Participate in aberrant data investigations.
• Conduct analytical data review including stability data.
• Disposition API Intermediates and raw materials, as appropriate.
• Provide coaching, feedback and mentoring to QA Specialists as it relates to execution of quality systems.
• Investigate customer complaints.
• Participate in and/or support recalls, as appropriate.
• Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), laboratory periodic reviews and equipment/computer system periodic reviews, as appropriate.
• Conduct gap assessments of global requirements and ensure implementation of the governing standards.
• Participate in and/or lead self-inspection activities.
• Participate in and/or support regulatory inspections and audits.
• Maintain and improve quality systems.
• Assist others in the interpretation of regulatory and corporate requirements.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees