GMP Support Specialist I Seattle Genetics
Bothell, WA

Job Description

Summary:

This position supports Facilities GxP (GMP & GLP) compliance by acting as a liaison between Facilities, QC, GLP and QA. This position is responsible for supporting Facilities related incident investigations, CAPA, CAPA effectiveness, audits and other Quality System activities. This position supports the Master Equipment File (MEF) system by providing oversight of the document filing system. This position helps maintain departmental training compliance by providing administrative support. This position may help support validation by assisting with periodic reviews and other qualification activities. Drafts Facilities SOPs and work practices.

Responsibilities:

* Ownership and primary responsibility for the MEF
* Acts as departmental training administrator: running reports, sending training reminders, submitting training extensions on behalf of Facilities and Engineering personnel
* Provides secondary documentation review within BMRAM and the calibration and maintenance program
* Leads efforts to champion SOP revisions through the QDM system
* Supports senior level specialist with deviation investigations, CAPA and Change Control
* Supports equipment qualification program by performing secondary protocol reviews and periodic review (PR)

Qualifications:

* Must have a minimum of 0-2 years of GxP experience in a regulated environment

Education:

* University degree

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.