Quality Control Specialist- Flow Cytometry

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.

This is an on site position based in Bothell, WA.

Position Summary:

The Quality Control Specialist provides support for flow cytometry quality control, in preclinical and/or clinical development within a Good Laboratory Practice (GLP) and Washington State Medical Test Site/ CAP Accredited environment.

Essential Functions:

• Quality control (QC) review and verification of scientific data which includes but is not limited to study/project related forms, data tables, equipment records, and reagent records.
• QC review of reagents in Safety Stratus Inventory Software
• Assists in preparing, scanning, and creating inventory for archival.
• QC of laboratory instruments by ensuring weekly/monthly maintenance on equipment is completed on a determined schedule.
• Scanning documents such as approved forms, requisitions, technical data sheets, documentation forms, etc. and storing in the appropriate secured locations.
• Communication with scientific colleagues via email or face-to-face.
• Facilitate adherence, understanding, and application of regulatory requirements.
• Assist in filing systems of current project binders and study related data.
• Creating archive indexes in MS Word, Excel, and Adobe Acrobat, as assigned.
• Adherence to protocols and standard operating procedures at all times.
• Perform other duties as assigned.

Job Requirements:

• Associates or Bachelor’s degree in a related field.
• 1-2 years of regulatory knowledge in a lab space is preferred.

Required Specialized/Technical Skills:

• Ability to work in a team-oriented environment, as well as work independently as needed.
• Understanding of regulatory requirements.
• Experience in Good Laboratory Practices and CAP regulations is beneficial but not required.
• Basic understanding of Flow Cytometry is preferred.
• Ability to effectively communicate, both written and oral.
• Demonstrates appropriate time management and prioritization skills.

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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