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 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.
现场QA负责审核生产的GMP文件。现场QA负责对生产区域进行日常的监督和支持，对发生的问题和批处理提供指导。现场QA负责取样和样品管理。作为团队的一员，现场QA支持包装的各个区域完成工厂的年度目标并帮助团队构建较强的质量意识。现场QA是保证GMP合规的关键，现场QA的活动包括，但不限于，审核和批准总结报告，审核批注，解决问题，取样，等。
The shop floor QA is responsible for the review of GMP documentation of production. The shop floor QA is responsible for providing daily oversight, assistance, and guidance to issues such as non-conformance evaluation, issue triage, and batch disposition activities. The shop floor QA is responsible for the sampling and QA sample management. The shop floor QA works as a team member supporting multiple package functions to achieve site goals while maintaining a strong quality mindset. The shop floor QA is essential for maintaining GMP compliance and includes, but not limited to, review / approval of cycle summary documentation, log review, issue resolution, sampling, etc.
Provide regular presence in operational areas to monitor GMP programs and quality systems.
Make initial decision of non-conformances that occur in the package area and escalate if necessary.
Review GMP documents (e.g., procedures, protocols, batch records, training records, logbooks).
Evaluate potential CQA impact for any GMP-related incident and support the investigation, as needed.
Be responsible for sampling, storage and distribution of identity sample, reserve sample and stability sample. Inspect annual samples and if necessary, be responsible for the management of samples.
Update or create procedures, as needed.
Participate in deviations, change controls and complaint investigation.
Participate in Six Sigma Projects or process improvement initiatives to help improve productivity within the quality organization and operational area.
Follow and understand good documentation practices and ensure the compliance of personnel operation. When necessary, mentor and educate personnel
Follow various HSE management procedures and fulfill the work safety responsibilities
Proven ability to work independently or as part of a team to solve issues.
Strong attention to detail.
Experience with SAP, PMX and TrackWise Deviation and Change Management processes
Strong oral and written communication and interpersonal skills
Overtime may be required
May be required to respond to operational issues outside of core business hours and days
Shift required
Demonstrate decision making and problem solving skills
Flexibility within job assignment
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does 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.
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