Quality Assurance Specialist/GLP Compliance, Development Quality

General Summary:

Eisai's corporate philosophy focuses on meeting the diverse needs of patients and their families and increasing the benefits that health care provides. We express this philosophy with the phrase "human health care," and continue to concentrate efforts on its realization worldwide. Throughout the company's 68 years of operation, drug discovery has been an integral part of its mission to advance human health care for patients and their families, as well as a major contributor to Eisai's success. Today, Eisai is Japan's third largest pharmaceutical company, ranking in the top 25 worldwide. Eisai's global R & D efforts are focused in several therapeutic areas, including central nervous system, oncology, gastrointestinal, and inflammatory diseases. Eisai in Andover, MA, is the center for product creation in the U.S., with an emphasis on finding new treatments for immune disorders and cancer.

We are seeking an individual to contribute to the success of our Pharmaceutical Science and Technology unit.  The Quality Assurance Specialist/GLP Compliance will assist with GLP compliance by participating in audits, training and system documentation.

Primary Responsibilities:

• Participate in the development of QA policies, procedures, protocols and quality standards.
• Review SOPs, deviations, investigations and change requests.
• Perform internal GLP audits to assure compliance.
• Perform vendor audits, including contract testing laboratories.
• Conduct and document internal GLP training.
• Conduct investigation for any compliance problems identified and generate corresponding report with recommended corrective action.
• Participate in the review of regulatory documents for IND and NDA submissions.

Qualifications: 

• BS or MS degree in Chemistry or related fields
• 5-10 years of pharmaceutical experience and 3-5 QA experience.
• Working knowledge of GLP and FDA regulations, especially as they relate to clinical APIs.
• Computer literate, familiar with Word, Excel and PowerPoint software and documentation database.
• Excellent communication skills (both oral and written) and the ability to balance multiple tasks.

For more information and other job postings, please visit the Eisai web site at: www.eisai.com
Eisai conducts background checks and pre-employment physicals
We are an equal opportunity employer M/F/D/V.