Job: Quality Associate II - III

Eisai Inc., Eisai Medical Research and Eisai Corporation of North America are U.S. subsidiaries of Tokyo-based Eisai Co., Ltd., a research-based human health care company, that discovers, develops, and markets products throughout the world.

At Eisai (a-zi), caring for people is our work. Satisfying unmet medical needs and increasing benefits to patients, their families, and caregivers is Eisai's human health care (hhc) mission. This includes the development of innovative medicines-notably the discovery of the world's most widely used treatment for Alzheimer's disease.

As a company growing at a fast pace, Eisai offers its employees opportunities to thrive. We recognize that our people are our greatest asset, and are committed to providing a work environment that will attract and retain talent. Eisai enables and empowers all employees to make significant contributions. That is our quest. That is our promise. That is what makes us Eisai.

With more than 2,500 employees in the U.S. and sites located in Woodcliff Lake, NJ, Ridgefield Park, NJ, Baltimore, MD, and Research Triangle Park, NC, we work and live by our values: Integrity, Respect, Professionalism, Quality and Teamwork.
Schedule, conduct and write reports for internal and external audits to ensure compliance with regulatory and internal CGMP standards. Evaluate audit responses and perform follow up to ensure closure of CAPA items. Maintain audit tracking, filing and scheduling systems. Support regulatory audits of Eisai production and contractor sites. Provide subject matter expertise on compliance issues. Participate as Quality Systems representative on projects and initiatives.
Bachelor's degree in science related field preferred. 4+ years of pharmaceutical quality audit experience. Aseptic and/or biotech background strongly desirable. Excellent written and oral communication skills. Experienced with investigative decision making and capable of developing solutions independently. Well developed attention to detail and ability to collaborate effectively with multiple functional groups. CQA certification preferred. Willing to travel up to 30% in position. Cooperative, impartial team player with professional demeanor.

At Eisai, we recognize that our employees are our greatest asset. That is why we reward them with highly competitive salaries, annual incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, Tuition and Health Club Reimbursement, and the list doesn't stop there. Since we intend to recruit "the best of the best" candidates, this is how we maximize our competitive advantage in the marketplace.

EOE



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http://eisai.contacthr.com/14401292