Eisai
QA Specialist (Hybrid)
North Carolina, Raleigh · Mid
Sponsorship not specified$66k-$87kDetected 119 days ago
SAPGMPFDA RegulatoryResearchCommunicationWritingMicrosoft OfficeGxP
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odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70
Thin sponsorship signal and lottery-bound (~15% per draw). A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card filing pattern in this occupation
Context, not a finding about this posting: of this employer's 3 green-card filings in this occupation, 100% were for a worker who already held the job.
Files H-1B transfers
2 transfer filings in the last year, covering 2 workers. Median labor-condition decision: 8 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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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.
Responsibilities
- 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.
Requirements
- 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.
Nice to have
- Biologics experience preferred.
Skills
- 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.
- Please click on the following link for more information:
- Right To Work
- E-Verify Participation
- Proficient in Microsoft Office tools.
- Strong organization and communication skills and technical writing skills.
Compensation
- Eisai Salary Transparency Language:
Benefits
- Knowledge and experience working with quality regulations to own area (e.g., experience working with regulated GMP systems and relevant health authorities).
Visa & Work Authorization
- 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.