Component Laboratory Technician Lead

Innovative Blood Resources • St. Paul, MN

2d

About The Position

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 operational, clean, neat, and well organized
• Any related duties as assigned.

Benefits

• comprehensive benefits (including medical, vision, dental, paid time off, and sick days)
• opportunity to participate in a 403(b)-retirement plan with a generous employer contribution

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees