QA Specialist (Hybrid)

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 plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to resolve quality-related issues.
Key responsibilities include:
• Reviewing and making disposition decisions for manufactured product batches.
• Supporting investigations and evaluating the impact of deviations or events on product quality.
• Acting as a Subject Matter Expert (SME) during regulatory inspections in assigned area(s) of responsibility.
This role requires a high level of independence, attention to detail, and strong communication skills to foster effective collaboration across teams.

Responsibilities

• Execute core processes within Quality area: 
  • Review manufacturing batch records for completeness, accuracy, and compliance with procedures to support timely product lot disposition.
  • Maintain associated documentation and records electronically in accordance with internal standards.
  • Support approval and issuance of Master Batch Records (MBRs)
  • Assist with entering events, change controls, and complaints into quality management system.
• Conduct ongoing tracking, documentation, and reporting of quality goals and metrics.
• Participate in process improvement activities aimed to add efficiency to Quality processes.
• Assist in the development, implementation, and maintenance of quality procedures and policies.
• Collaborate and assist in resolving Eisai Network and Business Partner queries and requests.

Qualifications

• Bachelor’s degree in a relevant scientific field with 2+ years of related quality experience OR equivalent education and work experience. (Knowledge of combination products and/or Biologics is a plus).
• Demonstrated experience across applicable quality assurance functions in a GMP setting (e.g., batch record review, SOP writing, auditing, batch release functions, deviation investigation and resolution, as applicable).
• Familiarity with applicable regulatory requirements (e.g., FDA, EMA, ICH) and quality systems.
• Strong oral and written communication skills.
• Strong attention to detail and ability to work independently.
• Exercises independent judgment in evaluating product disposition.

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Eisai Salary Transparency Language:

The base salary range for the QA Specialist (Hybrid) is from :63,300-83,100

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 https://us.eisai.com/careers-at-eisai/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:

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