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Quality Assurance Specialist

2 months ago

Marquand, Missouri, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Quality Assurance Batch Disposition Representative to join our team at Lilly. As a key member of our quality team, you will be responsible for ensuring the safe and efficacious release of drug products to the market.

Key Responsibilities
  • Perform batch disposition of incoming materials, semi-finished and/or finished drug product batches to ensure high quality medicine is released to market in a timely manner.
  • Lead, mentor, and coach operation and support personnel on quality matters associated with batch disposition.
  • Provide guidance in operational areas to ensure robust quality systems and GMP compliance.
  • Participate in self-led inspections and/or provide support during internal/external regulatory inspections.
  • Effectively review and approve GMP documents to ensure quality attributes are met.
Requirements
  • Bachelor's degree or equivalent in a science or engineering-related field.
  • Demonstrated relevant experience in a GMP facility.
  • Proficiency with applicable computer systems.
  • Demonstrated strong oral and written communication skills.
  • Demonstrated interpersonal skills and the ability to work as a team.
  • Root cause analysis/troubleshooting skills.
  • Demonstrated attention to detail and ability to maintain quality systems.
Preferred Qualifications
  • Proven ability to work independently or as part of a team to resolve an issue.
  • Previous experience with Lilly Event and Change Management process.
  • Proficiency with SAP, MES (PMX), and Darwin.
  • Previous experience in QC or QA is desirable.
About Lilly

Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. We are dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

We are an EEO/Affirmative Action Employer and do 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.