Follows all safety rules
Maintains accurate and complete training records
Understands and executes written procedures in accordance with cGMP
Operates basic filling equipment
Maintains detailed and accurate device history records
Completes and forwards devise history records for review in a timely manner
Stocks manufacturing area with supplies
Cleans manufacturing areas, to include lab ware, storage totes, equipment, shelves benches and sinks and removes trash
Assists with material handling and staging of materials for process orders.
Receives and verifies the accuracy of materials transferred from the Warehouse; may perform material and labor transactions in the ERP System;
may be responsible for flushing water ports and eyewash stations; applies labels according to SOP’s and performs refrigerator / freezer maintenance.
Responsible for maintaining laboratory environment in one functional area (multiple filling and / or bulking stations).
Maintain laboratory and laboratory stock.
Perform general lab audits to ensure compliance with current GMPs and regulations.
Perform equipment maintenance.
Open and close work orders; ensure ERP transactions are performed in a timely and accurate manner to ensure inventory accuracy.
Assist in the preparation of device master records & SOPs.
Train new lab personnel.
Formulation of subassembly solutions and small reagent bulks.
Responsible for decontamination, transportation, handling, and disposal of chemicals and biological waste (human serum).
Performs operation / calibration of all general lab equipment.
Knowledge, Skills and Abilities
General understanding of recordkeeping and mathematics. Working knowledge of laboratory science, procedures, techniques, instruments & equipment.
Working knowledge of general laboratory safety and record keeping. Knowledge of current GMP’s.
Blood Borne Pathogen training
Basic computer knowledge
Typically requires High School or AA
Typically 2-4 years of related experience or for AA 0-2 years of related experience
May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and / or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.