Component Laboratory Technician Lead

New York Blood Center Enterprises•St. Paul, MN

About The Position

Summary: This position is responsible for manufacturing and providing training and support in the manufacturing of blood products according to cGMP compliant policies and procedures. Ensures that all products meet the safety, purity, and potency requirements of the FDA, AABB and other regulatory agencies.

Requirements

High School Diploma or GED
2+ years of experience working in a laboratory/manufacturing environment

Responsibilities

Prepare and label products routinely according to Component Lab Standard Operating Procedures, including but not limited to red blood cell products, platelets, and plasma products.
Performs visual inspection of blood products at each step of processing.
Performs required equipment maintenance, trouble shooting and quality control on assigned instrumentation
Identify and report problems that may adversely affect products, perform corrections, if applicable, quarantine when required.
Obtain QC samples from blood products as assigned
Performs general laboratory maintenance as applicable
Monitor inventory of laboratory supplies
Quarantines products or supplies when required.
Unpack, receive, and inspect shipments containing blood products and/or donor samples.
Prepare shipments of donor samples, as required
Respond to environmental and storage alarms. Perform corrective action when necessary
Performs data entry into BECS and usage of applicable software
Generates various reports
Prepare specialty products as defined by department operating procedures
Assist with Level I training as assigned
Perform specialized tasks associated with research products as assigned
Execute qualification, validation, and verification protocols
Evaluate competency for non-CLIA tasks.
Manage inventory of laboratory supplies and order as needed
Investigate product holds and troubleshoot as needed
Assist in reviewing manufacturing records, as needed.
Perform and review lot release as applicable
Perform emergency product release
On call rotation where applicable.
Act as subject matter expert for laboratory equipment
Makes recommendations to improve business unit practices and processes.
Assist with Level I and II training.
Complete Quality Control review steps of all product types selected to be tested for QC before supervisory release.
Collaborate on controlled document creation and revision.
Assigning tasks to staff members.
Assign training tasks as needed to Level II and Level III staff members.
Train Level I, II and III Component Laboratory Technicians.
Enters component data into computer and verifies accurate interim labeling (as appropriate) by unit, to ensure physical inventories accurately reflect electronic records.
Ensures proper destruction and documentation of final disposition for all non-usable products.
Ensures the department, equipment and all product storage equipment are operation al , clean, neat, and well organized
Any related duties as assigned.