Quality Assurance Associate III

Location
Bothell, Washington
Posted
Apr 13, 2018
Ref
oq136fwk
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

The Seattle Genetics Quality Assurance team is dedicated to making the right product quality decisions for the protection of our patients.  The QA Associate III position is responsible for reviewing batch production records and associated documentation to assure product quality is consistent with established standards and in compliance with regulatory and industry expectations. 
 

Responsibilities:

  • Review cGMP Controlled Documents such as master batch production records, test methods, and specifications. Manage implementation of required changes to meet GMP and internal standards
  • Review executed batch production records to ensure compliance with approved procedures and GMP expectations. Communicate and resolve discrepancies with CMOs
  • Review and provide input into manufacturing deviations.  Track open deviations through to final closure
  • Review release data to ensure data accuracy, conformance to specifications and documentation standards
  • Participate in internal audits; write audit reports and follow up on observations/CAPAs
  • Participate in external audits of CMOs and other service providers; write audit reports and follow up on observations/CAPAs
  • Assist with the reporting and presentation of department metrics including Quarterly reports and Annual product reviews
  • Create and revise Standard Operating Procedures as needed
  • Represent QA and participate as QA Lead on CMC sub teams
  • Participate in regulatory inspections
  • Represent QA and participate as QA lead on electronic system sub teams as it pertains to MQA processes

Qualifications and Education Requirements:

  • Knowledge of cGMP and applicable FDA regulations
  • Bachelor’s degree in a scientific discipline or equivalent with 5+ years relevant industry experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA
  • Very detail oriented team player with effective planning, organization, and execution skills
  • Excellent communication skills with internal and external personnel essential
  • Experience with electronic systems such as Electronic Documentation Management System (EDMS), Quality Management System (QMS), and ERP (Oracle)
  • 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 quality and continuous improvement
  • Ability to anticipate and mitigate challenges
  • Experience supporting regulatory inspections desired
  • Occasional travel 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.