QA Batch Disposition

BioSpace, Inc.

Pleasant Prairie, Wisconsin, United States

Pleasant Prairie, Wisconsin, United States

About

Position Description The Quality Assurance Representative has oversight for the disposition of incoming materials, components, final disposition of semi‑finished products. As the authorized quality representative, you 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.
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
Basic 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 or visas for this role.
Additional Skills/Preferences
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
Additional Information
Day shift
Proven ability to work independently or as part of a team to resolve an issue
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.
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Pleasant Prairie, Wisconsin, United States

Languages

English

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