West-Ward Pharmaceuticals

  • ASSOCIATE SCIENTIST

    Job Location US-NJ-Cherry Hill
    Posted Date 5 days ago(5/17/2018 9:57 AM)
    Job ID
    2018-4396
    Job Function
    Manufacturing
    Shift
    1st
  • Overview

    This position supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of equipment, raw materials, and manufacturing processes.  Validation activities include research, protocol writing/execution and final report generation.  Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented.  Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.

    Responsibilities

    Under moderate oversight by senior team member or manager:

     

    • Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate. 
    • Performs a variety of projects/studies in areas that may include Product/Process, sterilization, Cleaning and Equipment Validation, as well as projects/studies to support Manufacturing Operations.
    • Writes protocols, reports (GTRs), Change Controls (including MARs).  Conducts Studies/Executes protocols. 
    • Serves as project lead with projects of intermediate scope and cross-functional teams.  
    • Mentors and provides leadership to junior team members. 

     

    Handles routine tasks timely, accurately. 

    Qualifications

    • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
    • Proficient in Microsoft Word and Excel, computer software.
    • Direct industry knowledge.
    • Ability to work independently or in teams.  
    • Ability to walk some distance 1-3 miles, stand for 3-6 hours and lift 10 - 40 lbs during the course of a work day as required.
    • Ability to work any shift (1st, 2nd or 3rd) and any day of the week (7 days) as duties require
    • Ability to become clean room gown trained/qualified and to work within the sterile suite areas for up to a full 8-hour shift (with appropriate breaks)

    Education and/or Experience:

     

    Minimum of a BA or BS preferably in the Sciences/Engineering/Math (other degrees accepted provided the individual has relevant experience -- e.g. education or employment in sciences or validations).

     

    This is an entry level position.

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