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Production Technician - Autoclave (Night Shift 3:00pm - 11:30pm)

Company: SeaSpine
Location: Irvine
Posted on: May 3, 2021

Job Description:

As an Autoclave Technician on our team, you will be responsible for maintaining the sterilization process to support manufacturing operations in compliance with the requirements of Standard Operating Procedures (SOP) per current GMP's, QSR and company policies, laws and procedures.

Essential Functions:

  • Maintain the disinfection (steam autoclave) process to support manufacturing activities
  • Wash and/ or wrap equipment and supplies
  • Load/unload drying oven and steam disinfection equipment
  • Input 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
  • Perform other job duties as assigned

Required Qualifications:

  • High School Diploma or equivalent
  • Must be able to communicate effectively with leadership and colleagues
  • Ability to adapt to a fast-paced environment
  • Must be punctual and have reliable attendance
  • Must be willing to work in a team environment
  • Must be proficient in tasks performed and have attention to detail
  • Ability to work overtime, including evenings, weekends, and holidays

Preferred Qualifications:

  • Prior experience in an FDA regulated manufacturing/controlled environment, preferably in medical device or human-tissue assembly/production
  • Knowledge of Good Manufacturing Practices (GMP)
  • 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

Keywords: SeaSpine, Irvine , Production Technician - Autoclave (Night Shift 3:00pm - 11:30pm), Other , Irvine, California

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