QA Sr. Associate/Sr. Specialist, Quality Programs & Compliance - Bothell, WA | Biospace
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QA Sr. Associate/Sr. Specialist, Quality Programs & Compliance

Seattle Genetics, Inc.

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Location:
Bothell, WA
Posted Date:
7/24/2017
Position Type:
Full time
Job Code:
2020
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Summary:

Seattle Genetics is seeking an energetic, passionate and experienced quality professional who will join the Quality Assurance team in the Quality Programs & Compliance group (QPC).

As a QA Sr. Associate / Sr. Specialist, the position will be responsible for managing or supporting the day-to-day QPC operations which may include risk management, data integrity, change management, deviations and CAPA, and will report to the Associate Director of Quality Programs & Compliance.

Responsibilities:

  • Manage the risk management system, including:developing risk management tools; generate and providing training; generating metrics; leading continual improvement activities
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  • Manage the data integrity system, including:assisting staff with performing data integrity assessments; providing training on using the assessment tools; leading continual improvement activities
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  • Support quality systems such as change management, deviations, CAPA and training, as needed, including:processing records, sending notifications, collecting metrics, etc.
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  • Support product recall activates and participate in continual improvement activities
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  • Represent Quality Assurance on cross-functional teams participating in various operational programs such as risk management activities and other continuous improvement activities
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  • Write/revise quality procedures or other department operating procedures
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  • Provide support for audits and inspections, as needed
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  • Supervise and mentor entry-level associates
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Requirements

Qualifications:

  • Bachelor's degree and 8+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry
  • Working knowledge of cGMP is required, including ability to understand and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance
  • Able to integrate learning from industry conferences or guidance documents into company procedures
  • Excellent written and oral communication skills required
  • Strong computer skills and working knowledge of general MS Office applications

Additional Skills:

  • Able to organize information in a consistent and readily retrievable manner
  • Enthusiasm for the work and ability to proactively implement continual improvements desired
  • Strong team player that can also work independently to achieve objectives

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.