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.

Essential Functions

• Execute core processes applicable to own area of internal/ external quality (e.g., deviation management; supplier assessment, product quality reviews, batch record review and product release, as applicable to the role).

• Review investigations to identify the root causes and relevant CAPAs.

• Conduct ongoing reviews and approvals of documentation (e.g., change control; validations and qualifications; product quality reviews, deviations, investigations, periodic reports, regulatory documents)as applicable to the role.

• Provide training and guidance to cross-functional teams around quality assurance aspects as required in the role.

• Support process improvements, risk assessments, and batch release.

• Support data analysis and development of reports and insights on quality metrics and key performance indicators, using digital tools and processes.

• Manage all inquiries and deliverables related to own quality area and communicate with internal and external stakeholders as applicable.

• Serve as the primary contact for quality area and coordinate across relevant cross-functional teams as required.

• Conduct ongoing tracking, documentation, and reporting of quality goals and metrics as per plans and contribute to the development and enhancement of effective quality processes within area.

• Develop, implement, and maintain quality procedures and policies to ensure adherence to company guidelines.

• Set goals, provide feedback, and coach team for better results.

Requirements

• Bachelor's degree, preferably in chemistry, biochemistry, or equivalent technical discipline with 4+ years of relevant experience in quality assurance.

• Demonstrated experience across quality assurance functions (e.g., batch record review, SOP writing, auditing, batch release functions, deviation investigation and resolution).

• Prior experience with quality in a cGMP setting.

• Experience working with regulated GMP systems and FDA, EMA, ICH, and JP regulations.

• Proven performance in earlier role.

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.

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