Sr. QA Associate
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POST DATE 9/1/2016
END DATE 11/1/2016
JOB DESCRIPTIONDepartment Name
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.
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.
KNOWLEDGE/SKILLS ABILITIES REQUIRED
BS/BA or MS in Chemistry, or closely related field required.
8+ years of senior level experience in Quality Assurance within the pharmaceutical or closely related industry. Prior supervisory experience preferred, but not required.
Demonstrated experience performing batch record review and isposition, investigating product complaints and conducting deviation investigations.
In depth knowledge of CGMPs and Regulatory Guidelines.
Strong interpersonal and communications skills (oral and written) required.
Demonstrated excellent customer service skills in dealing with external clients.
Demonstrated organizational skills.
Critical thinking and effective decision making skills with ability to identify issues requiring further attention, and ability to initiate and facilitate resolution of those issues in a timely & professional manner.
Strong attention to detail.
Strong interpersonal relationship skills; ability to work effectively across the organization.
Computer skills including a working knowledge of Microsoft Office (Access, PowerPoint, Word and Excel).
Working knowledge of Trackwise desirable.
Ability to work independently with minimal supervision and direction.
Auto req ID
Eisai is an Equal Opportunity Employer Minority / Female / Disability / Vet