Sr. GLP/GMP Auditor

 

 

 

Cell Therapeutics, Inc. (CTI), a Seattle-based pharmaceutical company, is committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. We strive to do business better than other pharmaceutical companies. Better means a more collaborative, well-trained team environment willing to institute novel approaches to scientific discovery and business opportunities. A willingness to push the limits and achieve challenging goals are the essential attributes that set CTI employees apart.

 

If you feel you have the skills and desire to work in our environment, we currently have the following exciting opportunity available:

 

Sr. GMP/GLP Auditor ? Job #2006B5IK


This position will be responsible for performing European and international field audits at various vendor facilities, summarizing audit findings in written report format, and performing trending analysis of findings.  Inspection activities will include: review of all elements related to GLP/GMP (EMEA, US FDA, ICH, and ISO) compliance including but not limited to: analytical testing, active pharmaceutical ingredient and finished dosage form production, labeling and vendor quality systems.  This position will be involved in assuring Corporate compliance with standard operating procedures, EMEA, ICH, and US FDA directives and regulations.  In addition, this position participates in the development, implementation and maintenance of GLP/GMP compliance systems and training programs; performs periodic vendor qualification inspections and assists in implementation of pre-approval inspection programs.  Requires a Bachelor?s degree in Life Sciences or equivalent and at least 4 years Quality Assurance experience in a EMEA and/or US FDA GLP, GCP, GMP and/or global ICH and ISO regulatory or related environment.  In addition this position requires 2 years audit and inspection experience, and batch record review and product release.  Experience with parenteral drug products is highly desired.

 

We offer a competitive compensation and benefits package as well as an environment where your contributions can make a significant difference.  To apply for any of our open position, please apply online at:

 

http://careers.celltherapeutics.com/

 

Please remember to reference Job #2006B5IK

Cell Therapeutics, Inc. (CTI)
Human Resource Development
201 Elliott Avenue W., Ste #400
Seattle, WA 98119
www.cticseattle.com

An Equal Opportunity Employer