Cary, North Carolina, United States · Hybrid
$66k–$87k/yr
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…
Skills: Batch Record Review, Documentation Management, Quality Assurance, cGMP Compliance, Veeva Vault
Durham, North Carolina, United States · On-site
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advanc…
Skills: VAD Coordination, Patient Assessment, Patient Education, Clinical Leadership, Heart Failure Management
Charlotte, North Carolina, United States · On-site
Our Company SpringHealth Behavioral Health and Integrated Care Overview Calling School Psychologists, LPs & LPAs Ready for More Impact SpringHealth Behavioral Health & Integrated Care of North Carolina is a clinically le…
Skills: Applied Behavior Analysis, Behavior Intervention Planning, Clinical Assessment, Crisis Management, Data Analysis
Charlotte, North Carolina, United States · On-site
Overview Magnera's purpose is to better the world with new possibilities made real. For more than 160 years, the originating companies have delivered the material solutions their partners need to thrive. Through economic…
Skills: Regulatory Compliance, Risk Assessment, Product Safety, Technical Writing, Cross-functional Collaboration
Waltham, Massachusetts, United States · On-site
$130k–$177k/yr
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you are part of the team at Thermo Fisher Scientific, you'll do meaningful work that makes a positive impact on a global scale! Join 8…
Skills: Financial Analysis, Pricing Strategy, Financial Modeling, Forecasting, Business Partnership
Mebane, North Carolina, United States · On-site
At ABB, we help industries run leaner and cleaner—and every person here makes that happen. You’ll be empowered to lead, supported to grow, and proud of the impact we create together. Join us and help run what runs the wo…
Skills: Prototyping, Electrical Testing, Material Handling, High Voltage Testing, High Current Testing
Durham, North Carolina, United States · On-site
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advanc…
Skills: Clinical Laboratory Testing, Specimen Handling, Instrumentation Calibration, Quality Control, Quality Assurance
Raleigh, North Carolina, United States · On-site
Join the Pharmaceutical Calibrations and Instrumentation (PCI) team! We are seeking a full time Instrumentation Specialist to perform repairs and maintenance on laboratory equipment at our client's pharmaceutical facilit…
Skills: Instrumentation Calibration, GxP Documentation, CMMS, Electrical Panel Safety, Negotiation
Morrisville, North Carolina, United States · On-site
MACOM (NASDAQ: MTSI) is a global leader in the design and manufacture of advanced semiconductor products across a diverse range of end markets, including Data Centers, Telecommunications, Industrial and Aerospace and Def…
Skills: High Performance Analog ICs, Circuit Analysis, Oscilloscopes, Spectrum Analyzers, Network Analyzers
Durham, North Carolina, United States · On-site
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advanc…
Skills: Clinical Laboratory Testing, Specimen Handling, Instrumentation Calibration, Quality Control, Quality Assurance
Hoke County, North Carolina, United States · On-site
$70k–$73k/yr
Amentum is seeking a Junior Geospatial Analyst to support the 389th MI BN process Exploit and Disseminate (PED) Information collected from identified sensors in Ft. Bragg, NC. The GEOINT Analyst will support the 389th MI…
Skills: Geospatial Analysis, PED, GEOINT, FMV Analysis, Intelligence Reporting
Lincolnton, North Carolina, United States · On-site
PRIMARY PURPOSE SUMMARY A Quality Engineer / Product Owner is responsible for the "end to end" quality system management for customer products. This ownership includes the development, supply, manufacturing, and customer…
Skills: Quality Assurance, Root Cause Analysis, Customer Relationship Management, Statistical Process Control, PFMEA
Durham, North Carolina, United States · On-site
$133k–$176k/yr
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can tran…
Skills: Molecular Biology, Protein Chemistry, Experimental Design, Data Analysis, Mentoring
Morrisville, North Carolina, United States · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Associate IRT Project Manager – Make an Impact at the Forefront of Science & Innovation At Thermo Fisher Scientific, you’ll di…
Skills: Project Management, IRT Solutions, Risk Mitigation, System Testing, Stakeholder Communication
Greenville, North Carolina, United States · On-site
Development Scientist II The Development Scientist II serves as a primary point of contact with the client regarding pharmaceutical development and clinical manufacturing project related activities. The Development Scien…
Skills: Pharmaceutical Development, Solids Formulation, GMP Compliance, Process Development, Project Management
Charlotte, North Carolina, United States · Remote OK
$98k–$149k/yr
Be a part of our mission! As a world leader in creating comfortable, sustainable, and efficient climate solutions for buildings, homes and transportation, it's our responsibility to put the planet first. For us at Trane …
Skills: Territory Planning, Strategic Relationship Management, Prospecting, Pipeline Management, Complex Sales
Raleigh, North Carolina, United States · On-site
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advanc…
Skills: CT Scanning, Patient Positioning, IV Placement, Contrast Administration, Radiation Safety
Hartford, Connecticut, United States · On-site
$85k–$212k/yr
Manager, Database Management Systems Job Summary Seeking an experienced clinical data professional to lead database management and clinical data standards activities supporting global clinical trials. This role will serv…
Skills: SAS Programming, Medidata Rave, CDISC Standards, SDTM, Clinical Data Management
Durham, North Carolina, United States · On-site
Please use Google Chrome or Mozilla Firefox when accessing Candidate Home.By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spirit at its best. Are yo…
Skills: Inventory Management, Data Entry, Quality Control, Shipping and Receiving, Cold Chain Logistics
Greenville, North Carolina, United States · On-site
Work Schedule 12 hr shift/nights Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail …
Skills: GMP Compliance, Sterile Manufacturing, Production Scheduling, Budget Management, Performance Management
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The QA Specialist supports external manufacturing quality operations by performing batch record reviews and managing documentation in Veeva Vault. They also assist with deviations, complaints, and quality system activities to ensure regulatory compliance.
Requires a Bachelor's degree in a scientific field with at least 2 years of QA experience in an FDA-regulated industry. Proficiency in Quality Management Systems like Veeva or TrackWise and experience in a GMP setting are essential.
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.
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 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:
At Eisai, human health care (hhc) is our goal.
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), with working on various activities together with global partners.
Offices: 4-6-10 Koishikawa, Bunkyo-Ku, Tokyo 1128088, JP
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