Sr. Quality Assurance Associate - Bothell, WA | Biospace
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Sr. Quality Assurance Associate

Seattle Genetics, Inc.

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Location:
Bothell, WA
Posted Date:
2/20/2017
Position Type:
Full time
Job Code:
1847
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Summary:

The Seattle Genetics Quality Assurance team is dedicated to making the right product quality decisions for the protection of our patients.  The Senior QA Associate position is a key member of CMC project teams interacting with CMOs.  This position is responsible for review and approval of batch production records and associated documentation to assure product quality is consistent with established standards and in compliance with regulatory and industry expectations.

Responsibilities:

   
        
  • Quality representative on internal and external CMC project teams with decision making authority

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  • In conjunction with technical representatives - review and approve manufacturing and testing Deviations/CAPAs

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  • Review and approve cGMP Controlled Documents such as master batch production records, test methods, specifications and manage implementation of required changes to meet GMP and internal standards

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  • Review executed batch production records to ensure compliance with approved procedures and GMP expectations. Communicate and resolve discrepancies with CMO's

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  • Review release test and stability data to ensure data accuracy, conformance to specifications and documentation standards

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  • CoA approval

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  • QA disposition of product intermediates

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  • Conduct internal/external audits of CMO's and other service providers, write audit reports and follow up on observations/CAPAs

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  • Assist with the reporting and presentation of department metrics including annual product reviews

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  • Write and review Standard Operating Procedures as needed

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  • Participate in regulatory inspections

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Requirements

Qualifications:

  • Bachelor's degree in a scientific discipline or equivalent with 8+ years relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing/QC or QA

  • Knowledge of cGMP and applicable FDA/international regulation

  • Detail oriented team player with effective planning, organization, and execution skills

  • Excellent communication skills with internal and external personnel essential

  • Experience with electronic documentation management systems (EDMS)

  • Strong computer skills with Word and Excel

  • Ability to work effectively at a fast pace with cross functional departments

  • Innovative, proactive, and resourceful: committed to continuous improvement

  • Ability to anticipate and mitigate challenges

  • Ability to make risk based decisions

  • Experience working with clinical and commercial products and supporting regulatory inspections desired

  • Experience in Small Molecule and Biologic manufacturing desired

  • Ability to travel domestically and internationally up to 10% of time

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.