ICOS Corporation

Quality Assurance Compliance Specialist, Bioanalytical Laboratory

Location(s): Seattle, WA

ICOS Corporation, based in the Seattle, Washington area, has spent more than a decade building a world-class research and development organization. Our lead product Cialis® (tadalifil) for the treatment of erectile dysfunction recently received US FDA approval and is currently launched in over 50 countries worldwide. ICOS is committed to advancing science in the areas of protein based and small molecule therapeutics.

If you have experience in QA Compliance within the Pharmaceutical or Biotech industry and want to work in the fast paced environment of a growing company then consider this position at ICOS Corporation.

Responsibilities

Primary responsibilities: Collaborate with GLP study personnel in the Bioanalytical laboratory and management to provide assurance that GLP studies are in compliance with FDA GLP regulations, internal standards and SOPs. This includes:

• Identify procedural and systematic compliance risks and recommend practical corrective actions that compliment functional area business process.
• Audit external GLP facilities to review and assess processes and systems to assure GLP compliance.
• Provide compliance support for bioanalytical work contracted out.
• Conduct/facilitate GLP training classes as needed.

Requirements

• BS/BA in life sciences, preferably in Chemistry.
• Minimum 2 years experience in a GLP environment preferably as an auditor.
• Understanding of bioanalaytical work and or familiarity with LC-MS-MS and HPLC instrumentation.
• Pharmaceutical/biopharmaceutical industry preferred.
• Working knowledge of FDA GLP regulations and 21 CFR Part 11 regulations.
• Excellent communication skills and the ability to influence and collaborate with clients are essential.
• Ability to travel 15% of time.
• Strong attention to detail and demonstrated ability to identify quality and systems issues are required.

ICOS offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.

For immediate consideration please email your CV to Karen Fenstermacher at kfenstermacher@icos.com highlighting the position in the subject line or visit www.icos.com and apply directly for this position.

Learn more about ICOS’ philosophies, attributes, financial information, and more by visiting our web site at: www.ICOS.com.

ICOS Corporation
Reference Job Code: 1636SB0304
Karen Fenstermacher

Email: kfenstermacher@icos.com

ICOS Corporation is an Equal Opportunity Employer

Submitted: 03/30/2004