Contingent Worker - MFG Process Technician

Orthofix•Irvine, CA

4d•Onsite

About The Position

The technician is responsible for prepping and packaging of supplies to support the build plan and forecast demands. Assisting Manufacturing Supervisor / Manager in overseeing production team to ensure all production operations are in compliance with SOP's, current GMPs, QSR, GTP, and ISO standards as well as company procedures.

Requirements

High School Diploma or equivalent required
Experience in an FDA-regulated manufacturing environment, preferably in a Medical Device manufacturing environment
Mathematical skills
Knowledge of Good Manufacturing Practices (GMP)
Individual must be punctual and have reliable attendance
Individual must be cooperative and willing to work in a team environment
Must be able to follow direction provided by authorized supervision
Must have the ability to multi-task in a fast-paced environment
Must be willing to learn different jobs in the manufacturing environment
Must be able to perform repetitive task(s) consistently and proficiently
Must be able to speak and read English with excellent understanding
Must be able to keep legible and correct documentation of activities
Must be proficient in tasks performed (after suitable training period) and have attention to detail
Ability to utilize a computer, telephone, label printer and copy machines as well as other general office equipment.
Ability to work overtime, including evenings, weekends and holidays

Nice To Haves

Knowledge of Lean Manufacturing and Six Sigma Green or Black Belt
Knowledge of Quality System Regulation (QSR) and International Organization for Standardization (ISO)
Medical device manufacturing/assembly/packaging experience
Experience working in a controlled environment (preferably ISO class 5, 7 & 8 or better)
Oracle ERP experience

Responsibilities

Supports formulation build of products.
Supports preparation and verification of components.
Follows SOP requirements for cleaning, labeling, and sealing of processed units.
Supports ERP move and material transactions are completed timely.
Follow Company policies and procedures compliance.
Properly transfer and stock supplies for all controlled areas (i.e. autoclave, clean room and quality areas)- complete system transactions where applicable (for inventory control purposes)
Supports ERP move and material transactions are completed timely.
Assist with final packaging activities, such as but not limited to, kitting and prepping lots.
Assist in main clean room activities, as required
Assist in organizing delivered gowning supplies from approved vendor and stocking of gowning supplies in the Gowning Room.
Assist in performing waste water treatment for proper disposal.
Assist with daily general cleaning and performs other job duties as assigned.
Perform other job duties as assigned