QA Validation Associate (Manufacturing/Process/Analytical)

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POST DATE 9/11/2016
END DATE 10/12/2016

Seattle Genetics, Inc. Bothell, WA

Company
Seattle Genetics, Inc.
Job Classification
Full Time
Company Ref #
360817
AJE Ref #
576138140
Location
Bothell, WA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

Summary:

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 validation support for product development teams
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 processes and methods
Organize and file validation plans, protocols, data, and reports in controlled document system


Responsibilities:

BS/MS degree in science, engineering, or related field with 2+ years of relevant industry experience in Quality Assurance, Quality Control, Process Sciences or Manufacturing
Working knowledge of cGMP and the ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance is required
Familiarity with analytical method and/or process validation from either a technical or quality standpoint
Excellent written and oral communication skills
Enthusiasm and ability to proactively implement continual improvements
Ability to organize information in a consistent and readily retrievable manner
Position may require some travel; ability to travel is required