ICOS Corporation

Quality Assurance/GMP Compliance Specialist

Location(s): Seattle, WA

ICOS Corporation, based in the Seattle, WA area is a leader in the discovery and development of breakthrough, proprietary products with high commercial potential for the treatment of serious medical diseases. The company's leading product, Cialisr for the treatment of erectile dysfunction, was recently launched in over 50 countries.

Responsibilities

The successful candidate will be responsible for planning, scheduling and performing GMP compliance audits of third party manufacturers, contract laboratories, contract service providers, and key suppliers. Specific responsibilities include:

• Vendor review preparation and meetings.
• Scheduling, coordinating, and conducting audit.
• Generating and updating audit reports and evaluating responses.
• Determining final vendor status.
• Maintaining vendor database information.

Requirements

• Minimum of 5 years experience in the pharmaceutical / biopharmaceutical industry in the areas of QA, QC, or Manufacturing (or a combination).
• Bachelors/Masters degree in a scientific discipline (Chemistry, Biology or Life Sciences Preferred) with a Certified Quality Auditor designation is strongly preferred.
• Previous auditing experience in the areas of documentation and external vendors is strongly preferred.
• Working knowledge of cGMPs; able to interpret cGMPs for other ICOS employees; may be considered an 'expert' for one or more sections of the GMPs.
• Able to interpret company policies, company procedures, industry / regulatory guidance and GMP regulations to make independent decisions.
• Basic mathematical and statistical skills.
• Experience with product development and GMP compliance audits.
• Ability to work on unusually complex technical problems and provide solutions which are highly innovative and ingenious.
• Working knowledge of pharmaceutical Good Manufacturing Practices.
• Understanding of basic scientific principles and a sound understanding of quality systems.
• Able to interact constructively with peers, superiors and external contacts.
• Able to communicate ideas effectively both verbally and in writing and to facilitate change.
• Computer literacy is required.
• This position requires the ability to travel both domestically and internationally.

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: 1617AT0404
Karen Fenstermacher


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Phone:
Fax:
Email: kfenstermacher@icos.com

ICOS Corporation is an Equal Opportunity Employer

Submitted: 05/04/2004