QC Specialist I - Blood Typing Solutions

GRIFOLS, S.A.•San Diego, CA

13d•Onsite

About The Position

Grifols Diagnostic Solutions Inc is seeking a Quality Control Specialist 1 to join our Immunohematology Quality Control department for Reagent Red Blood Cells (RRBC) and Gel Cards in San Diego, CA. This position will be reporting to the QC Supervisor. The QC Specialist has a strong understanding of products (QC testing, specifications, QC processes, assay knowledge) within the assigned workcell. This role may act as as Lead for their workcell, scheduling activities, communicating with Production Planners.

Requirements

Bachelor’s degree in Biological Sciences or Chemistry
4 years of relatable QC experience
Working knowledge of Enterprise Resource Planning (ERP), QSR, GMP/GLP requirements
Working knowledge of industry/regulatory standards
Intermediate computer skills
Some technical writing skills
Problem Solving
Attention to detail

Nice To Haves

Experience working and handling blood products

Responsibilities

All QC Support Analyst 4 responsibilities
Executes experiments for troubleshooting non-conformances and/or assay technique issues
Participates in quality audits (QC assessments, internal, 3rd party)
Initiates and leads document change control activities. Able to create/revise QC documents (procedures and specification documents).
Supports the work-cell lead with test scheduling
Acts as a lead trainer for QC work-cell
Initiates clear and concise LI/OOS investigations
Performs and documents investigations using standard root cause determination methods
Initiates clear and concise non-conformances. Performs and documents low severity investigations
Leads a QC department team or participates on cross-functional teams