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Aseptic Operator II/III

Company: Actalent
Location: Fort Collins
Posted on: September 20, 2022

Job Description:

Description:The Aseptic Operator is responsible for performing room and equipment cleaning and sanitization, bulk drug product formulation, equipment preparation, and aseptic fill finish batch production per applicable work instructions using a variety of pharmaceutical and lab equipment within critical cleanroom environments.Essential Duties/Responsibilities: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Follow detailed work instructions, standard operating procedures, and batch record process steps to produce aseptically filled sterile drug product.
  • Comply with policies, guidelines, and regulatory requirements of the Quality System and applicable current Good Manufacturing Practices (cGMPs).
  • Report problems with quality, processes, equipment, or materials to the Lead Aseptic Operator and Supervisor, Aseptic Operations.
  • Maintain the cleanliness and operational readiness of the critical aseptic processing and support areas through routine cleaning, sanitization, cleanroom consumable stock maintenance, and environmental monitoring.
  • Complete applicable logbook, form, and batch record documentation as required while adhering to strict cGMP and internal good documentation practices.
  • Complete routine tasks with minimal supervision.
  • Complete initial aseptic gowning and process qualification and maintain qualification to work within Grade A and Grade B (ISO 5) cleanroom environment.
  • Other duties as required and assigned by Aseptic Operations Management.Additional Skills & Qualifications:
    • Ability to read and comprehend procedures written in English
    • Ability to complete paperwork accurately in English
    • Ability to work safely around chemicals and equipment
    • Ability to stand or sit for long periods of time
    • Ability to do repetitive work, requiring strong dexterity and hand/eye coordination
    • Ability to aseptically don sterile gowning materials
    • Must be able to work in a controlled cleanroom environmentExperience:
      • Previous critical environment or cleanroom Manufacturing experience within regulated industry preferred
      • Previous ISO 7 or ISO 5 clean room experience preferredExperience Level:Intermediate Level About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Fort Collins , Aseptic Operator II/III, Other , Fort Collins, Colorado

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