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QA Validation Associate

Seattle Genetics, Inc.

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Location: Bothell, WA Posted Date: 4/16/2013 Position Type: Full time Job Code: 1303TP-01 Required Education: High school or equivalent

Description

•   Perform QA reviews of analytical method validation, process validation, cleaning validation and/or shipping validation studies including reviewing protocols, executed protocols/validation data, and associated validation reports.
•   Provide QA support for computerized system validation projects and equipment qualification projects, as required.
•   Provide QA validation support for product development teams, as needed.
•   Monitor validated processes and evaluate trends.
•   Provide validation support for audits and inspections, as needed.
•   Maintain validation logs and schedules, review validation exceptions to determine impact on validation studies, and review proposed changes to assess impact of changes on validated systems.
•   Organize and file validation plans, protocols, data, and reports in controlled document system.

Requirements

•   BS/MS degree in science, engineering, or related field with 5+ years of relevant industry experience supporting analytical method validation and laboratory equipment qualification
•   Prior experience in two or more of the following:  method validation, process validation, cleaning validation, shipping validation, and computerized system validation
•   Previous experience working with change management systems is desired
•   Working knowledge of cGMP is required, including ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance
•   Proven ability to apply statistical principles in a pharmaceutical setting is a plus

Additional Skills:
•   Excellent written and oral communication skills required
•   Enthusiasm for the work and ability to proactively implement continual improvements desired
•   Proven ability to work effectively in a fast paced team environment
•   Must be able to organize information in a consistent and readily retrievable manner
•   Prior experience applying risk assessments to validation projects
•   Experience and/or industry training in process monitoring to support process validation
•   Familiar with statistical process control

Physical Requirements:
•   Position may require some travel; ability to travel is required.

Seattle Genetics is an equal opportunity employer.
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