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BioFact:
(1984) U.S. Patent Office stuns U.S. industry by announcing, in response to Japanese Patent Association submission, that any plant falling under the 1930 Plant Patent Act or the 1970 Plant Variety Protection can not also be patented under the 1980 patent law.
ATC clean room constructors...validation guaranteed!
ICOS Corporation
QA-GMP Compliance Associate III
ICOS Corporation, based in the Seattle, Washington area, has spent more than a decade building a world-class research and development organization. Cialis is currently available in approximately 100 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. ICOS is committed to advancing science in the areas of protein based and small molecule therapeutics.
Responsibilities:
Provide Quality Assurance/GMP Compliance support for biologics API Manufacturing.
- Review and approve site SOPs and master production records.
- Review and approve completed solution and production records and associated data.
- Authorize product changeover.
- Participate in quality programs such as deviation investigation review/evaluation, CAPA and Change Management.
- Participate in maintaining facility compliance.
- Support client projects by serving as Quality project team representative.
Requirements:
- B.S. in chemistry or life sciences.
- Five+ years of relevant experience in a pharmaceutical or FDA/GMP environment.
- Strong knowledge of FDA and EU regulations.
- Ability to understand and apply GMP regulations and relate them to daily manufacturing operations.
- General understanding of manufacturing and laboratory operations.
- Computer literacy required.
- Demonstrated ability to effectively manage multiple tasks utilizing organization and prioritization skills, self motivated.
- Strong interpersonal, written and oral communication skills.
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: 2326
Karen Fenstermacher
Email: kfenstermacher@icos.com
ICOS Corporation is an Equal Opportunity Employer
Submitted: 11/22/2005
