QC Analyst II/III

Summary :

Performs with intermediate to advanced proficiency lab support activities and participates in basic routine and non-routine microbiological testing and general QC laboratory work in support of Seattle Genetics’ clinical development and / or commercial products in a GMP testing environment.

Principal Responsibilities :

Applies the principles of good manufacturing practices (GMP) in a QC laboratory on a daily basis

Conducts routine and non-routine analyses of microbiological samples in accordance with standard operating procedures (SOPs)

Performs cleaning verification and / or validation testing support in accordance with standard operating procedures (SOPs) and aligned to industry requirements and best practices

Performs environmental monitoring and sampling of water and gas clean utilities

Performs analytical testing of in-process manufacturing samples, including bioburden and endotoxin

Creates and revises standard operating procedures (SOP’s) and other documents as needed including but not limited to cleaning verification / validation protocols and final reports

Performs troubleshooting of laboratory and / or system anomalies with limited guidance

Performs maintenance of QC lab equipment, procedures and systems

Conducts laboratory investigations, as needed

Authors and owns deviations, CAPAs and Change Controls

Identifies, participates and / or leads continuous improvement projects

Performs method or system development and / or optimization

Trains other personnel, as needed

Serves as SME for test methods or other areas of expertise

Fully complies with company health and safety procedures and practices

Weekend, on-call and shift work may be required

Required Qualifications :

2+ years relevant laboratory experience (Analyst II)

5+ years relevant laboratory experience (Analyst III)

Bachelor's degree in the biological sciences

Broad experience with Microsoft Office products

Experience with basic lab equipment (e.g. pH meters, balances, pipettes)

Preferred Qualifications :

General knowledge of aseptic technique and microbiology concepts

2+ years of cGMP laboratory experience in the biopharmaceutical industry

2+ years of microbiological testing experience

2+ years of analytical testing supporting cleaning verification / validation

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.