Plasma Process Lab Tech

PURPOSE

Operates under the direct supervision Operations Supervisor. Follows and adheres to buyer specifications. Ensure there are no out-of-compliance conditions when processing the plasma or samples. Complete tasks accurately and in compliance, to set the example for employees under their lead.

General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company, and any other applicable regulatory standards.

ESSENTIAL RESPONSIBILITIES & DUTIES

• Ensure product integrity by ensuring compliance with Food and Drug Administration (FDA) regulations, state regulations, ABO’s Standard Operating Procedures (SOP), and any other applicable regulatory standards.
• Organize product in storage freezer, ensuring freezer organization is complete and consistent.
• Perform the QA review of donor samples.
• Perform the QA review of product to be shipped to the consignee.
• Assist with the process flow in the lab, ensuring the bottles are entering the freezer in the proper time frame.
• Coordinate Daily Activities in Processing Area
• Make daily assignment in coordination with manager
• Provide preventive maintenance as scheduled on equipment: centrifuge, heat sealers, thermometer, internal freezer thermometers and graph recorders, and calibrate as necessary
• Observe technicians for compliance
• Assist with destroying unacceptable units. Quarantine and discard unacceptable samples and products.
• Manage flow of units coming through the window and ensure compliance in accordance with the SOP.
• Facilitate training of new lab team members in coordination.
• Set up, operate and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control).
• Maintain instruments used for processing and storage of donor samples and products.
• Document operational and maintenance activities when necessary.
• Determine supply inventory requirements; order and restock, as needed.
• Communicate delays and other issues to center management, and/or other necessary parties.
• Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.
• Any other duties as assigned.

REQUIREMENTS

• High school diploma or equivalent (Must be able to show proof)
• Strong customer service skills.
• Must be proficient in English (Read, Write, Speak) with legible handwriting
• Current CPR card
• Proficient with computer entry
• Prior supervisory skills preferred
• Certified as a Trainer
• Six months’ experience in Plasma Processing (Requirements can be changed by Management, depending on knowledge, skills and abilities.)
• May be required to travel for training

PHYSICAL DEMANDS

Performing the responsibilities of the job requires ability to use hands and fingers to handle and feel objects, tools or controls; reach with hands and arms. Frequently required to stand, walk, climb and balance; and stoop, kneel, or crouch. Required to stand for extended periods of time (2-4 hour intervals). Ability to lift, tug, and pull up to 50 pounds.

WORK ENVIRONMENT

This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May be exposed to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment required such as protective eyewear, lab coat, gloves and freezer jacket/gloves/pants. Work in a walk-in freezer for short intervals of time (-20C or colder).