Contingent Worker - MFG Process Technician
On-siteIrvine, California, United States
Job Summary
Prep and package supplies to support build plans and forecast demands, verifying components and ensuring all production operations comply with SOPs, GMPs, QSR, GTP, and ISO standards. Perform formulation build support, cleaning, labeling, and sealing of processed units while managing ERP move and material transactions for inventory control. Stock controlled areas including autoclaves and clean rooms, assist with kitting, lot preparation, waste water treatment, and daily general cleaning. Transfer and stock gowning supplies from approved vendors and maintain legible documentation of all activities. Work in a fast-paced FDA-regulated medical device environment, multi-tasking to perform repetitive tasks consistently while following company policies and procedures.
Required Qualifications
- High School Diploma or equivalent
- Experience in an FDA-regulated manufacturing environment
- Mathematical skills
- Knowledge of Good Manufacturing Practices (GMP)
- Punctuality and reliable attendance
- Willingness to work in a team environment
- Ability to follow direction provided by authorized supervision
- Ability to multi-task in a fast-paced environment
- Willingness to learn different jobs in the manufacturing environment
- Ability to perform repetitive task(s) consistently and proficiently
- Ability to speak and read English with excellent understanding
- Ability to keep legible and correct documentation of activities
- 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
- Ability to perform repetitive motion involving substantial movements of the wrist, hands and/or fingers; or grasping with hands and/or fingers
- Ability to perform some standing
- Ability to perform some bending, stooping, kneeling, or crouching
- Ability to perform some walking
- Ability to perform frequent or continuous moderate lifting of 15-40lbs
- Ability to perform frequent or continuous pushing and/or pulling
- Ability to perform frequent or continuous repetitive motion involving substantial movements of the wrist, hands and/or fingers; or grasping with hands and/or fingers
- Ability to work in a controlled environment (preferably ISO class 5, 7 & 8 or better)
- Oracle ERP experience
Desired Qualifications
- 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
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