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Operator, II

Req ID: J2260963

  • Ubicación
    West Chester, Pensilvania, United States of America
  • Categoría Manufactura
  • Publicado martes, 2 de marzo de 2021
  • Tipo Tiempo completo

Descripción del Trabajo

OVERALL RESPONSIBILITIES:  

  • Processes and packages various medical devices and biomaterials product in a controlled environment room  

 

POSITION DUTIES & RESPONSIBILITIES:  

  • Performs duties and responsibilities as required per work instructions, training guides and S.O.P. guidelines  

  • Set-up and operate various production equipment used to grind, weigh, measure, dry, mold, ultrasonic, assemble, laser etch and sterile package biomaterials and other medical devices 

  • Requires a high level of concentration and attention to detail to ensure that products are properly labeled and packaged 

  • Performs testing and gowning duties and responsibilities required per process sheets, work instructions and training guides 

  •  Follow all procedures in a controlled environment  

  • Perform equipment set up and PM’s when necessary  

  • Keeps accurate and up-to-date batch records and data sheets on batches in-process 

  •  Calibrate balances and weigh raw materials  

  • Complete Quality Records as they relate to the manufacturing process 

  • Performs SAP transactions and enters required computer data for each packaged product  

  • Prints LMD, LPPF and BOM and all required packaging labels and performs label reconciliation 

  • Maintains manufacturing areas in accordance with operating procedures and Lean philosophy 

  • Strives to maintain product quality at all times while working towards continuous improvements 

  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times  

  • Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer  

  • Works in other production areas as needed  

  • Performs other related duties, as required  

 

EDUCATION & EXPERIENCE REQUIREMENTS:  

  • High School Diploma (minimum) 

  •  Clean room lab technician experience required. (Measuring of powders and liquids) 

  • Medical device packaging a plus.  

  • Computer experience with Windows, Manuscript, JDE and Label Software a plus  

  • Has the ability to recognize equipment and product problems, and perform basic troubleshooting  

  • Ability to work as a team and multitask in a controlled environment room to meet production schedule  

  •  Demonstrated experience in compliance, quality, and productivity.  

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