Valeant Pharmaceuticals

  • Aseptic Prep Documentation Specialist

    Location US-FL-Tampa
    Job ID
    10153
    Category
    Operations
    Pos. Type
    Full Time
  • Overview

    Position days and hours are Monday - Friday (8:00am - 4:30pm)

    Responsible for providing robust support systems for manufacturing processes. This position will support ongoing improvements to the existing processes and manufacturing equipment. Assure the purity, strength, and safety of sterile and non-sterile products via cleaning, disinfection, preparation and sterilization of the aseptic and non-sterile manufacturing areas and equipment. This position required Aseptic Gowning certification, Rinse Water Certification, Disinfection and all related EHS and functional training to maintain the GMP hours. Assumes responsibility for the GMP, ISO, environmental health and safety procedure awareness, and compliance within the respective area.

    Responsibilities

    1. Support of Aseptic Prep activities in the pursuit of daily excellence. Assist the GL and Supervisor in all Aseptic Prep processing.
    2. Perform, maintain, and review batch records, logbooks and forms in the Prep Area.
    3. Update and maintain the SOP's binders, processing logbooks and forms according with the cGMP in Aseptic Prep and Compounding          area.
    4. Support the Aseptic Prep. Business Unit
    5. Support Manufacturing and QA investigation while interacts with internal technical resources and internal customers.
    6. Support improvement of the Aseptic Prep batch record.
    7. Perform aseptic prep operator functions. Disassembles, cleans, and prepares precision filling and compounding equipment for sterilization. Loads and operates autoclaves, dry heat oven, and   CIP/SIP skids for the cleaning and sterilization of manufacturing equipment in accordance with the production schedule. Generates and interprets sterilization cycle data, verifies cycle parameters and performs release of cycles for manufacturing use.
    8. Ensures SOP's are read and provides technical SOP training.
    9. Understands and enforces daily area compliance in safety/EHS procedures, GMP, and SOP/batch record adherence. Audits area to  assure compliance. Evaluates quality performance with the Team   Leader and/or Manufacturing Quality Assurance. 
    10. Review new and revised procedures in a timely fashion. Support OpEx initiative. Perform WISE OWLS observations. Maintain GMP  hours and EHS training. All other duties as assigned.

    Qualifications

    High school or Technical/Associate degree in science.

    Good communication and documentation skills.  Ability to work in an aseptic environment.  Ability to work different shifts/weekends as needed to maintain the production schedule. Ability to work with multiple departments/management. Basic computer/office applications (email, Word, Excel). Must be detail oriented and quality conscious.

    Maintain Aseptic Gowning Certification, Critical Cleaning Certification, and Rinse Water Certification.

    Must be able to read, write and speak English and possess basic math skills.

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