Aseptic Operator, IV Bag Manufacturing I - All shifts available at Xellia Pharmaceuticals ApS


Aseptic Operator, IV Bag Manufacturing I - All shifts available
Quality

Position Summary

The contents contained in this job description are the minimum requirements required to be met for the aforementioned position. Under the direction of area management or designee, the Aseptic Operator I is responsible for performing all necessary tasks both in and outside of the classified manufacturing suites in support of manufacture of safe and effective sterile (injectable) pharmaceutical products at the Xellia Cleveland plant.

Key Responsibilities

  • Perform job functions with in compliance of 21CFR part 210 and 211, FDA, OSHA and other regulatory agencies.
  • Ensure that the current requirements for Environmental, Health, Safety (EHS) issues are met within the production operations.
  • Ensure training compliance for assigned curriculum prior to performing any work task
  • Set-up, Operation, and troubleshooting of key manufacturing equipment: including (but not limited to) lyophilizer, autoclave, parts washers, filler, capper, CIP/SIP skid, etc.
  • Documentation of perform tasks as per established Good Documentation Practices, and review of executed documentation (batch records, logbooks, etc.) in a timely manner.
  • Assist in the execution of equipment/process qualification, validation, and protocols as required.
  • Assist in development and creation of departmental procedures to include but not limited to SOPs, OJTs, and work instruction documents
  • Participate in investigations, and execute appropriate approved corrective / preventative actions for Aseptic Core related processes.

Requirements

  • Required: HS Diploma/GED
  • Preferred: Associates Degree
  • 0-1 year of related work experience in a cGMP environment / or cGMP trade certificate or similar experience
  • General computer skills proficiency
  • Military service highly desirable

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals

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