At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Job Summary

The Quality Assurance Associate III is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Eisai Raleigh facility. The primary areas of concern for this role are:

• working with other stakeholders to resolve quality issues with Contract Manufacturers by assisting in the investigation process and evaluating the potential impact of any event or deviation on the disposition of the associated product,


• responsibility for the disposition decision for the commercial and clinical products manufactured for Eisai,


• supporting Regulatory Agency audits at Eisai by being a Subject Matter Expert in the assigned area.

The Quality Associate III must be able to perform the associated tasks independently and demonstrate a high-level of professionalism and effective teamwork by developing strong relationships with peers, internal customers and management through effective oral and written communication.

Essential Functions

• Ensure that all manufacturing batch records are received and executed per procedure and meet all quality requirements by reviewing for completeness, compliance, and accuracy to support product lot disposition.


• Electronically maintain all associated documentation and records


• Assist with reviewing CMO authored Annual Product Reviews/Product Quality Review and completing the Eisai APR/PQRs for assigned products


• Support approval and issuance of Master Batch Records (MBRs)


• Assist and document investigations into deviations and complaints


• Review/Initiate Global Change Controls


• Review/prepare Annual Product Reviews/Product Quality Reviews


• Provide support for Eisai Network associates and Business Partners


• Assist and manage reference standard requests


• Enter and review release & stability data into LIMS as needed


• Participate in process improvement activities aimed to add efficiency to Quality processes.


• Collaborate and assist in resolving Eisai Network and Business Partner queries and requests

Requirements

• Bachelor's degree (preferably in science related discipline).


• 5+ years of pharmaceutical/biotech experience.


• Strong oral and written communication skills.


• Ability to interpret and apply cGMPs, relevant laws, guidance documents and directives


• Strong attention to detail and ability to work independently.


• Exercises independent judgment in evaluating product disposition.


• Hands-on experience with batch record review and product disposition is preferred

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

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