Associate - QA Batch DispositionEli Lilly and Company • Concord, California, United States
Associate - QA Batch Disposition
Eli Lilly and Company
- Concord, California, United States
- Concord, California, United States
À propos
Organisation Overview Lilly is entering an exciting period of growth and is investing over $1,000,000,000 to create a new state‑of‑the‑art manufacturing site in Concord, North Carolina. The site will support the production of parenteral medications, device assembly and packaging operations, with a focus on minimizing environmental impact.
Job Responsibilities
Support the development and execution of the site readiness plan, focusing on the e‑release process and the startup of new systems.
Perform final batch disposition of semi‑finished and/or finished drug products and combination product batches to ensure GMP compliance and timely release to market.
Effectively own, review, and approve GMP documents (e.g., deviations, procedures, protocols, specifications, and change controls) to ensure quality attributes are met.
Additional duties as required.
Basic Requirements
Bachelor’s degree in STEM.
Experience working in the pharmaceutical or medical device industry in QA roles.
Previous batch disposition experience.
Ability to make technical decisions and provide guidance to the site.
Proficiency with applicable computer systems.
Strong oral and written communication skills.
Interpersonal skills and ability to work as part of a team.
Root‑cause analysis and troubleshooting skills.
Attention to detail and ability to maintain quality systems.
Experience with regulatory inspection readiness and execution.
Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites.
Legally authorized to work in the United States; no visa sponsorship will be provided.
Additional Skills & Preferences
Ability to work 8‑hour days – Wednesday through Sunday (Day Shift; no remote work).
Ability to work overtime and be on‑call as required.
Proven ability to work independently or as part of a team to resolve issues.
Experience with Event and Change Management processes.
Proficiency with SAP, MES, and Trackwise.
Experience with device and parenteral product materials.
Accommodation Statement Lilly is dedicated to helping individuals with disabilities actively engage in the workforce. If you require accommodation to submit a resume, please fill out the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for assistance. Requests will be treated confidentially.
Lilly is a proud 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.
Compensation & Benefits Actual compensation will depend on education, experience, skills, and geographic location. Anticipated annual wage ranges from $65,250 to $169,400. Full‑time employees are eligible for company bonuses, a 401(k) plan, pension, vacation benefits, medical, dental, vision, prescription drug benefits, flexible benefits (including healthcare and dependent day‑care). Additional benefits include life insurance, death benefits, leave of absence benefits, employee assistance program, fitness benefits, and employee clubs and activities. Lilly reserves the right to modify compensation and benefit programs at its discretion.
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Compétences linguistiques
- English
Avis aux utilisateurs
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