Production Tech Autoclave I (2nd Shift)

Orthofix•Irvine, CA

10d•$20 - $23

About The Position

The Production Technician-Autoclave is responsible for completing manufacturing assignments as directed by the Manufacturing Manager and/or the Production Supervisor. Typical duties and tasks must be completed in compliance with the requirements of Standard Operating Procedures (SOP) per current GMP’s, QSR and company policies, laws and procedures.

Requirements

High School Diploma or equivalent required
0-2 years of experience in an FDA regulated manufacturing/controlled environment, preferably in a Medical Device Experience or human-tissue assembly/production.
Must be able to speak, write and read English with excellent understanding
Ability to adapt to a fast-paced environment
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
Knowledge of Good Manufacturing Practices (GMP)
Ability to perform repetitive task consistently and proficiently
Must be able to interact with peers, Manufacturing Supervisor/Manager
Must be proficient in tasks performed (after suitable training period) and have attention to detail
Ability to work overtime, including evenings, weekends and holidays
Ability to utilize a computer, telephone, label printer and copy machine as well as other general office equipment.

Nice To Haves

Knowledge of Quality System Regulation (QSR) and International Organization for Standardization (ISO)
Experience working in a controlled environment (preferably ISO class 5, 7 & 8 or better)
Oracle ERP experience

Responsibilities

Maintain the disinfection (steam autoclave) process to support manufacturing activities.
Wash and/ or wrap equipment and supplies.
Loading and unloading of drying oven and steam disinfection equipment.
Place purchase requisitions for production spare parts and tooling, as necessary
Verify cycle printouts and logbooks.
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)
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
Compliant with company policies and procedures
Assist with daily general cleaning and performs other job duties as assigned.
Perform other job duties as assigned