QA Specialist

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. The QA Specialist, External Manufacturing Quality Operations (EMQO) supports Quality Assurance activities at the Eisai Raleigh facility by assisting with routine operational quality tasks under direction and supervision. This role contributes to batch record review, documentation management, investigation support, and quality system activities to ensure compliance with cGMPs, internal procedures, and regulatory requirements. The QA Specialist, EMQO works collaboratively with internal stakeholders and business partners while developing foundational QA knowledge and skills. Essential Functions: * Responsible for document archival in Veeva Vault, ensuring accuracy, adherence to documentation standards, and preservation of full traceability, integrity, and completeness. * Assist in the development, implementation, and maintenance of quality procedures and policies to ensure adherence to company guidelines. * Maintain quality documentation and records in electronic systems in accordance with established procedures. * Review manufacturing batch records for completeness, accuracy, and compliance with procedures to support product disposition. * Support release activities by coordinating documentation readiness and collaborating with QA team members and cross-functional teams. * Support deviation, complaint, and investigation activities by gathering data, documenting findings, and tracking actions under supervision. * Collaborate with Eisai Network partners and Business Partners to respond to all quality inquiries and deliverables. * Participate in audits and inspections in a supporting role, such as document retrieval and response preparation. * Conduct ongoing tracking, documentation, and reporting of quality goals and metrics of own area of quality. * Contribute to continuous improvement initiatives and support efficiency within Quality processes. Requirements: Education: * Bachelor's degree in a relevant scientific field with 2+ years of related in Quality Assurance in an FDA-regulated industry OR equivalent education and work experience. Technical: * Experience or familiarity with Quality Management Systems (e.g., Veeva, TrackWise) * Demonstrated experience across key quality assurance functions in a GMP setting (e.g., batch record review, batch release functions, GxP document archival, as applicable). * Knowledge and experience working with quality regulations to own area (e.g., experience working with regulated GMP systems and relevant health authorities). * Experience or familiarity with SAP inventory system. * Proficient in Microsoft Office tools. * Proven performance in earlier role. * Biologics experience preferred. Must Possess: * Strong organization and communication skills and technical writing skills. * Strong attention to detail with the ability to follow procedures accurately. * Must be self-directed, goal-oriented, and quality conscious. * Demonstrates a strong learning mindset and receptiveness to feedback. * Exhibits professionalism, integrity, and accountability. * Builds effective working relationships with peers and cross functional partners. * Ability to work a hybrid schedule (a minimum of 3 designated onsite days - T, W, TH) * Values consistent with Eisai Values and ONE Team Behaviors together with an intrinsic understanding of Eisai's hhc Mission and the need to always think first of the Patient. Eisai Salary Transparency Language: The annual base salary range for the QA Specialist (Hybrid) is from :$66,200-$86,800 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit us/en/compensation-and-benefits . Certain other benefits may be available for this position, please discuss any questions with your recruiter. 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: Right To Work E-Verify Participation