Qa Batch Disposition Jobs

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 35,000 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:
The Quality Assurance Batch Disposition Team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The QA Batch Disposition is responsible final disposition of Semi-Finished and/or Finished drug combination products. The QA position is essential for ensuring GMP compliance in the qualification, validation, control strategy and startup of operations to ensure regulatory approval of the facility. Electronic batch records with high integration and focus on data integrity will be utilized to confirm manufacturing production.

Responsibilities:

• Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls)
• Performs final batch disposition of semi-finished and/or finished drug product and combination product batches, to ensure high quality medicine (GMP Compliance) is released to market in a timely manner
• Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process and startup of new systems

Basic Requirements:

• Proficiency with applicable computer systems
• Demonstrated attention to detail and ability to maintain quality systems
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
• Previous batch disposition experience
• Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites
• Ability to make technical decisions, provide guidance to the site
• Previous regulatory inspection readiness and inspection execution experience
• Root cause analysis/troubleshooting skills
• Demonstrated interpersonal skills and the ability to work as a team
• Demonstrated strong oral and written communication skills
• Experience working in the pharmaceutical or medical device industry in QA roles

Education Requirements:

• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent experience
• Demonstrated relevant experience in a GMP facility

Additional Skills/Preferences:

• Proven ability to work independently or as part of a Team to resolve an issue
• Previous experience with device and parenteral product materials
• Proficiency with SAP, MES, and Trackwise
• Previous experience with Event and Change Management process
• Previous facility or area start up experience

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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