Eisai

QA Specialist (Hybrid)

North Carolina, Raleigh

Sponsorship not specified$66k-$87kDetected 26 days ago

SAPGMPFDA RegulatoryResearchCommunicationWritingMicrosoft OfficeGxP

About the role

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.
If this is your profile, we want to hear from you.

Responsible for document archival in Veeva Vault, ensuring accuracy, adherence to documentation standards, and preservation of full traceability, integrity, and completeness.
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.
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.

Experience or familiarity with Quality Management Systems (e.g., Veeva, TrackWise)
Experience or familiarity with SAP inventory system.
Proven performance in earlier role.
Strong attention to detail with the ability to follow procedures accurately.
Must be self-directed, goal-oriented, and quality conscious.

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 https://careers.eisai.com/us/en/compensation-and-benefits.
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai Inc. participates in E-Verify.
Proficient in Microsoft Office tools.
Strong organization and communication skills and technical writing skills.

The annual base salary range for the QA Specialist (Hybrid) is from:$66,200-$86,800

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.
Knowledge and experience working with quality regulations to own area (e.g., experience working with regulated GMP systems and relevant health authorities).

As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.

re, 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 statu

This listing is sourced directly from Eisai's careers page and normalized into a canonical job model.