QA Batch Disposition

Lilly • Pleasant Prairie, WI

7d • $65,250 - $169,400 • Onsite

About The Position

The Quality Assurance Representative has oversight for the disposition of incoming materials, components, final disposition of semi-finished products. As the authorized quality representative, serve as a technical leader within Quality to ensure proper adherence to Global and Local Quality requirements and ensure that there are adequate quality systems in place related to the Batch Disposition process to ensure product released to the market meets applicable GMP standards. This role is essential for ensuring GMP compliance in the qualification, validation, control strategy and startup of operations to ensure regulatory approval of the facility.

Requirements

• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study.
• 2+ years previous batch disposition experience supporting device, parenteral or drug substance products/materials.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Demonstrated relevant experience in a GMP facility
• Experience working in the pharmaceutical or medical device industry in QA roles
• Previous batch review and disposition experience
• Ability to make technical decisions, provide guidance to the site
• Proficiency with applicable computer systems (MasterControl, SAP, Darwin)
• 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
• Previous regulatory inspection readiness and inspection execution experience
• Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
• Proven ability to work independently or as part of a Team to resolve an issue

Responsibilities

• Performs batch records review for Component Preparation, Formulation, Filling, Visual Inspection, Environment Monitoring and audit trail review of semi-finished batches
• Performs final batch disposition of semi-finished product batches, to ensure high quality medicine (GMP Compliance) is released to market in a timely manner
• Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: non-conformances, procedures, protocols, specifications, and change controls)
• 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

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• 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: Mid Level