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Compounder

Company: Renaissance LLC
Location: Lakewood
Posted on: November 16, 2020

Job Description:

Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Overview

Entry level position to Compounding Department with emphasis on ensuring that equipment used to process aseptic and non-aseptic products has been cleaned, sanitized or sterilized, as required by specific documentation or procedures. This entails performing automated and manual equipment cleaning prior to sterilization, placing cleaned equipment into autoclaves, starting and monitoring autoclaves, unloading equipment from autoclaves, and delivering equipment to areas of use.

Perform Clean-In-place (CIP) and Steam-In-Place (SIP) functions as required by specific documentation or procedures.

Maintain work area and equipment on a daily basis to ensure compliance. Work area is maintained at level to sustain organization of supplies and equipment. Area is kept clean and sanitized as required by current and applicable procedures. Equipment is kept in an organized and compliant manor.

Introduction to compounding functions as deemed necessary by operations management and functions where qualified to perform.

Responsibilities

  • Follow manufacturing procedures specific to the task being performed.
  • Support to compounding functions as deemed necessary by operations management and functions where qualified to perform. Support may include active batching functions.
  • Operation of processing equipment, and the execution of manual and automated cleaning, sanitizing, and sterilization of tanks and equipment.
  • Perform integrity testing of filters using automated filter integrity test equipment.
  • Able to follow detailed diagrams and written instructions to assemble or disassemble equipment, configure equipment to be washed, configure equipment to be autoclaved.
  • Show progression in competency in all aspects of the position.
  • Demonstrate aptitude and capability to perform multiple tasks at the same time.
  • Able to successfully pass sterile gowning qualification within a 1 month time limit.
  • Perform environmental monitoring at grade level C and D room classifications
  • Utilize knowledge to actively demonstrate process trouble-shooting capabilities whenever possible.
  • Ability to maneuver drums and equipment in excess of 50 lbs and the capability to lift weights up to 50 lbs.
  • Maintain accurate and complete documentation in fulfillment of all duties.
  • Understand and comply with current SOP and GMP requirements relevant to the position.
  • Maintain professional, courteous, and effective communication with all co-workers, customers, and contractors in the execution of all job functions.
  • Perform job responsibilities in a safe and efficient manner, maintaining a clean work environment. Assist supervisors and process manager in all other duties as assigned.
  • Proper use of personal protective equipment at all times is required.
  • Perform routine maintenance on process equipment.
  • Perform area cleaning to maintain compliance using phenolic cleaners and sporicidal agent. A full face respirator or PAPR will be required to be worn for this position.
  • Review MBRs throughout process to assure compliance to good documentation practices.
  • Be available for unscheduled and scheduled overtime throughout the work week and weekend when requested.

    Qualifications

    EDUCATION:

    High school diploma or general education degree (GED) required.

    EXPERIENCE:

    A minimum of 1-3 years of relevant experience in the pharmaceutical industry; laboratory experience at the secondary education level. Aseptic manufacturing experience preferred.

Keywords: Renaissance LLC, Lakewood , Compounder, Other , Lakewood, New Jersey

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