Immunomedics, Inc.

  • Manufacturing Specialist I

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(11/6/2019 9:06 AM)
    Job ID
    2019-1565
    # of Openings
    4
    Category
    Scientific Manufacturing/Production
  • Overview

    Responsible for pharmaceutical manufacturing in compliance with current Good Manufacturing Practice (cGMP) 

    Responsibilities

    • Ensures consistent completion of all the planned manufacturing activities assigned to him/herself. 
    • Minimize waste of the resources (worktime, materials, and components). 
    • Organize workplace to maximize the throughput and minimize risks of errors. 
    • Follow well defined procedures closely, with attention to detail. 
    • Practice strong aseptic technique. 
    • Document activities accurately and clearly as per GDP. 
    • Operate manufacturing equipment according to well defined procedures. 
    • Daily monitoring of the process. 
    • Minor maintenance of manufacturing equipment as trained. 
    • Preparation of media, supplements, and/or buffers, where applicable. 
    • Revise/draft standard operating procedures (SOPs) as necessary. 
    • Report and document deviations, when encountered. 
    • Troubleshoot and recommend corrective/preventive actions (CAPAs), where applicable. 
    • Ensurethat organizational KPI’s are consistently achieved. 
    • Draft deviations, CAPAs, and/or change controls, where requested. 
    • Review completed manufacturing records for accuracy. 
    • Ensure compliance in operations. 
    • Proactively communicate and escalate to management any outstanding issues, or concerns of a compliance, quality, safety, or any other critical matter. 

     

    It is each employee’s responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee’s responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function. 

    Qualifications

    • High School Diploma required. Associates degree/Bachelor’s degree in the sciences or engineering discipline with 0 to 1 years’ experience in a cGMP manufacturing industry or 2-4 years of proven work experience.  
    • Effective communication (oral and written), organizational, and interpersonal skills. 
    • Ability to work well within a team environment. 
    • Ability to document clearly and accurately as per GDP. 
    • Ability to follow SOPs as written. 
    • Possess strong aseptic technique. 
    • Be proficient with MS Office. 
    • Have an aptitude for troubleshooting. 
    • Be proactive in identifying, communicating and escalating issues. 
    • Have ability to closely review documentation as per GDP. 

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