Quality Assurance, Sr. Specialist

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POST DATE 9/8/2016
END DATE 10/9/2016

Seattle Genetics, Inc. Bothell, WA

Company
Seattle Genetics, Inc.
Job Classification
Full Time
Company Ref #
360711
AJE Ref #
576116181
Location
Bothell, WA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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p span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Summary: /span /span /p p span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" The Seattle Genetics Quality Assurance team is dedicated to making the right product quality decisions for the protection of our patients. The QA Senior Associate/Specialist position is responsible for managing vendor qualification and external compliance programs to assure product quality is consistent with established standards and in compliance with regulatory and industry expectations. /span /span /p p /p p span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Responsibilities: /span /span /p ul li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Maintain state of the art audit program /span /span /p ul li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Generate GMP audit and site visit schedules /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Facilitate planning, execution and follow up of vendor assessments /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Develop metrics and key performance indicators (KPIs) /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Perform audits /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Maintain approved vendor list /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Track audit commitments and ensure appropriate follow-up /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Establish auditor qualification program /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Maintain audit documentation in a compliant manner /span /span /li /ul /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Establish and maintain Quality Agreements with external suppliers /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Manage Vendor Complaint Program /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Manage receipt, review and tracking of vendor Product Quality Reviews /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Regulatory Support /span /span /p ul li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Act as a liaison with external sites to fulfill requests to support regulatory filings, license renewals, etc. /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Develop a system for maintaining and tracking vendor GMP Certificates, manufacturing certificates; etc. /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Coordinate fulfillment of QP requests for external CMO documentation /span /span /li /ul /li /ul ul li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Inspectional support /span /span /p ul li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Ensure notification of vendor inspections are distributed internally and to partner as required /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Develop and maintain a system to track regulatory inspection histories for vendors /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Support regulatory inspections at CMOs. In conjunction with European office, act as a point of contact for CMOs when a vendor is inspected. /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Coordinate fulfillment of documentation and informational requests for vendor site inspections /span /span /li /ul /li /ul p /p