Process Technician - Irvine, CA (92618)
Shift: 2nd Shift, 3pm-11pm
Pay: $19 - $23/hour
Overview:
The Process Technician is responsible for prepping and packaging of supplies to support the build plan and forecast demands. Assisting the 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.
Duties and 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
Minimum Requirement:
- 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.
- Strong computer skills are required.
Preferred Qualifications:
- Medical device manufacturing/assembly/packaging experience.
- Experience working in a controlled environment (preferably ISO class 5, 7 & 8 or better).
Physical Requirements:
- This position requires frequent or continuous bending, stooping, kneeling, or crouching.
- This position requires frequent or continuous moderate lifting of 15-40lbs.
- This position may require some pushing and/or pulling.
- This position requires frequent or continuous repetitive motion involving substantial movements of the wrist, hands and/or fingers; or grasping with hands and/or fingers.
Medix is acting as an Employment Agency in relation to this vacancy.