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Senior QA Associate

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POST DATE 9/13/2016
END DATE 10/14/2016

Eisai Inc. Baltimore, MD

Company
Eisai Inc.
Job Classification
Full Time
Company Ref #
360838
AJE Ref #
576161664
Location
Baltimore, MD
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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The Senior QA Associate functions as a subject matter expert for the QA department. Represents QA on cross-functional department teams and serves as the group leader in the absence of department manager. Reviews executed documents to ensure that the documentation has been executed per procedure and meets all quality requirements. Responsible for the disposition decision for commercial product manufactured at Eisai Baltimore. Leads and conducts investigations in collaboration with the production unit to fully understand the impact of the deviation and determine appropriate CAPA. Investigates product complaints and conducts follow-up with customer. Drafts or contributes to QA documentation, including standard operating procedures, and annual product reviews (APR)/product quality reviews (PQR). Trends Quality data. Trains other QA personnel on procedures. Requires minimal direction and supervision while functioning as a senior member of the QA department.

The position is critical to ensuring that Organizational, Site, and Departmental objectives and goals such as Uninterrupted Supply of Product and a Responsive Supply Chain are obtained. The Senior QA Associate is an individual contributor with no direct reports. Senior QA Associate receives no instruction on routine work as these tasks are described in detail in established procedures and standards. Receives general instructions on new assignments. Provides an independent compliance review of their peer s work prior to final management approval. May work on problems and investigations of diverse scope where they exercise judgment within generally defined practices and policies, knowledge of CGMP, job-related experience. They independently determine whether the product manufactured by Eisai meets standards and is acceptable for distribution to Eisai patients. The Senior QA Associate is expected to perform their core job functions with minimal supervision and input from management.

ESSENTIAL RESPONSIBILITIES

Reviews executed commercial production records in a timely manner, ensuring that records are in compliance with GMP s and standard operating procedures. Upon completion of review, assigns the appropriate disposition.

Functions as a subject matter expert for the QA department. Represents QA on cross-functional department teams and serves as group leader in the absence of department manager.

Conducts, writes and performs risk assessments for investigations/deviations in collaboration with the production unit to fully understand the impact of any deviation. With assistance from the production unit, determines root cause and assigns appropriate CAPA.

Product Complaints Contacts customers, conducts and writes investigation, trends complaints, collaborates with the production unit to fully understand the impact of the complaint, and with assistance from production unit determines/assigns appropriate CAPA

Drafts or contributes to QA documentation, including investigation reports, standard operating procedures, and annual product reviews (APR)/product quality reviews (PQR). Trends Quality data.

Other duties as assigned to facilitate ongoing Eisai Baltimore/Gliadel production and/or operational activities including, but not limited to:

Involving Eisai-Baltimore, ECL, and external partners and companies

Review Out Of Calibration report, weekly alarm trends and Labeling change controls.

Executes AQL inspections and sampling

Performs Area Clearance and In Process inspections to support Gliadel production

Periodically summarizes status and progress of assigned activities as requested by supervisor.