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GMP Compliance Technician

2 months ago


Topeka, Kansas, United States Fagron GmbH & CO. KG Full time

We are looking for a Cleanroom Operations Specialist to become a vital part of our team at Fagron GmbH & CO. KG. This role will be under the supervision of the manufacturing manager.


Key Responsibilities:
  • Conduct thorough reviews of batch documentation to ensure compliance with cGMP standards.
  • Support process enhancements, including managing change control processes.
  • Update and maintain Standard Operating Procedures (SOPs).
  • Assist in the creation of production schedules.
  • Oversee logbook management for the cleanroom and assist with document retention practices.
  • Help with inventory management within the cleanroom environment.

Profile/Experience Requirements:
  • A minimum of two years of experience in a manufacturing cleanroom setting.
  • Strong communication skills and the ability to collaborate effectively with team members.
  • Meticulous attention to detail, ensuring a low error rate in documentation.
  • High school diploma or equivalent educational background.
  • Familiarity with cleanroom protocols and regulations.
  • Understanding of and adherence to CGMP (Current Good Manufacturing Practices) regulations.
  • Proactive attitude, with the ability to seek assistance and offer support as needed; capable of working independently.
  • Effective time management skills, with the ability to prioritize tasks and adapt to changing demands.
  • Capability to manage multiple responsibilities and organize resources to meet deadlines.
  • Basic proficiency in computer and mathematical skills.
  • A positive mindset and the ability to thrive in a collaborative team atmosphere.

What We Offer:

At Fagron, we provide a vibrant workplace where talent and ambition can flourish. Our organizational culture is open and informal, encouraging individuals to be self-motivated and work autonomously.

As a rapidly growing international pharmaceutical company, we offer numerous opportunities for professional development.

The position includes a competitive salary, comprehensive benefits, a performance package, and the chance to be part of a leading organization in an expanding industry.


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