Sr. Associate, QA Analytical; R2 – R3

Senior Associate, QA Analytical (R2 – R3)

Provide quality assurance analytical oversight for Product Research & Development (PR&D) and associated collaboration partners. Provide quality oversight for molecule testing labs, analytical equipment, perform audits and lab walkthroughs, and assess quality documentation and data.

• Provide quality oversight for molecule testing labs and analytical equipment.
• Perform audits and lab walkthroughs.
• Assess quality documentation and data.
• Ensure quality systems are in place, utilized, and in a state of control.
• Facilitate quality improvement initiatives and implement new quality standards.
• Assess potential impact of incidents and ensure appropriate review for deviations, change controls, and out of specification results.
• Perform quality assurance review of GMP documentation and ensure compliance with internal standards and applicable regulations.

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering, or a related field.
• 4 years of experience with quality assurance and control in a pharmaceutical setting.
• Minimum of 1 year experience each with: comprehensive document reviews (manufacturing batch records, QC methods, protocols, reports, validation documents); review and approval of method validation and technology transfer documents in compliance with ICH and FDA guidance; review of logbooks, QA batch disposition, and QA support; support QA for contract manufacturing organizations; supporting QA equipment validation documents (IQ, OQ, PQ) and maintenance/calibration of equipment.
• Up to 10% domestic and international travel required.

• Location:
  
  Indianapolis, IN.
• Travel:
  Up to 10% domestic and international.
• Position Status:
  Full-time.

• Anticipated wage: $ - $ per year.
• Bonus:
  Eligible for a company bonus based partly on company and individual performance.
• Benefit Program:
  Company-sponsored 401(k) and pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life and death insurance; time off and leave of absence benefits; well-being benefits (employee assistance program, fitness benefits, employee clubs).

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.