Quality Control Manager/Sr. Manager - Bothell, WA | Biospace
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Quality Control Manager/Sr. Manager

Seattle Genetics, Inc.

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Location:
Bothell, WA
Posted Date:
9/18/2017
Position Type:
Full time
Job Code:
1991
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Summary:

Seattle Genetics Quality Control is looking for a person with vision and capability to help manage our electronic systems as we continue to grow.


 Responsibilities:

This position will be responsible for managing QC computer systems currently in use, interfacing these systems with each other and with the lab needs, and planning for future systems to support GMP quality control testing and QC data management. Working closely with Information Systems, Quality Assurance, the equipment management team, and other members of QC, this position will help coordinate and lead teams that ensure data integrity and electronic robustness throughout QC. This position will also supervise a small group of knowledgeable analysts and managers, providing guidance and prioritization as needed.

Requirements


Qualifications:

  • A strong and comfortable interface with complex computer systems
  • Experience in computer system validation per the requirements stated in 21CFR Part 11 and Annex 11 of the EU GMPs
  • A knowledge of quality control testing requirements, GMPs, and regulatory compliance
  • Previous work with a LIMS system that manages inventory, testing, test results, and stability
  • Organizational skills
  • Strong team working ethic
  • Flexibility
  • Technical writing
  • Experience supervising a team of capable analysts and managers


Desired qualifications

  • Background interfacing multiple systems and/or working across multiple sites is a plus
  • Knowledge and background in equipment qualification for a GMP or GLP laboratory is a plus
  • Knowledge of the StarLIMS system is a plus

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.