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Dendreon Corporation
Quality Assurance Associate (Sr/I/II) – Quality Compliance, Apheresis Auditor
Location: Seattle,
Washington-Seattle
98121
Posted on:
10/27/2009 2:21:06 PM
Postion type:
Full time
Job Code:
5856
Required Education:
NOT PROVIDED
Salary:
DESCRIPTION
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company applies its expertise in antigen identification, engineering, and cell processing, to produce active cellular immunotherapy product candidates designed to stimulate a cell-mediated immune response. Dendreon is traded on the NASDAQ Global Market under the symbol DNDN.
Dendreon is seeking a QA Associate (Senior/I/II) who will be responsible to provide direct support for the oversight of all aspects of compliance and vendor qualification activities for the Dendreon Network of aphaeresis collection centers. The Dendreon Quality Compliance group works to facilitate a positive and collaborative relationship with our suppliers. If you thrive in a fast-paced, highly technical environment and you are capable of handling complex assignments with minimal direction, please send us your resume.
General Summary:
• Conducts qualification audits of potential collection centers and periodic audits of approved aphaeresis suppliers to ensure compliance with applicable FDA Good Tissue Practices (GTP) and current Good Manufacturing Practices (GMP). Responsible for scheduling audits, developing audit plans, leading the audit team, writing audit reports and following up on audit responses and corrective actions.
• Serves as the primary Quality Compliance advisor to the Aphaeresis Team for all GTP and federal regulation issues and concerns.
• Maintains the approved supplier list specific to Dendreon contracted aphaeresis collection centers.
• Assists in the development and maintenance of procedures related to quality systems aphaeresis related functions.
• Provides Quality Compliance support on cross functional project teams to ensure compliance with applicable regulations.
REQUIREMENTS:
• Bachelor’s degree in science, nursing, or equivalent with experience in a biopharmaceutical environment preferred.
• Typically a minimum of 2 years working in quality, development or regulatory organization; experience with blood, plasma or blood products or equivalent.
• Experience conducting external supplier audits and managing contractors
and/or having worked in a hospital or blood center preferred.
• Strong knowledge of GTP, cGMP and related FDA regulations.
Working Conditions and Physical Requirements:
• Up to 50% travel may be required.
Benefits
We offer a competitive compensation and benefits package, including bonus, matching 401(k) & stock options. Please visit http://dendreon.com/careers/ to submit your resume.
The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.
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