Hikma Pharmaceuticals USA Inc.

  • Qual Lab Assoc II-Chem

    Job Location US-NJ-Cherry Hill
    Posted Date 6 days ago(8/8/2018 9:58 AM)
    Job ID
    2018-4705
    Job Function
    Quality
    Shift
    1st
  • Overview

    Perform functions of the Chemistry Laboratory and conduct chemical and physical analyses on pharmaceutical products through all stages of the manufacturing process from incoming components and raw materials to finished goods and stability. Execute process and cleaning validation and/or test method validation under the direction of supervision. Write/revise standard operating procedures, forms and exception reports. The duties also include equipment maintenance and LIMS management

    Responsibilities

    • Conduct critical biochemical, chemical and physical analyses on raw materials, initial, in-process, final products, and stability programs. Work under minimum supervision.
    • Serve as Mentor to Quality Laboratory Associate (QLA) I positions. Provide training and work direction for QLA I positions as required.
    • Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.
    • Use sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of biochemical and chemistry principles. Perform calibrations and maintenance as required.
    • Perform advanced biochemical and chemical assays requiring precise analytical skills and understanding of biochemical and chemistry principles.
    • Complete all testing, including special project / protocol testing in a timely and appropriate manner.
    • Maintain data integrity and ensure compliance with company SOPs and specifications, USP/Ph Eur, FDA, GDP and cGMP regulations.
    • Investigate deviations and write exception documents.
    • Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
    • Perform laboratory and manufacturing audits as required (cGMP, safety, housekeeping, etc.). Make necessary corrections as needed.  
    • Responsible for maintaining laboratory housekeeping, cleanliness of laboratory equipment and work benches, and other general lab responsibilities as assigned by supervisor.

    Qualifications

    Proficient in wet and instrumental methods of analyses. Advanced laboratory skills, basic knowledge of statistical method. Strong technical problem solving skills. Ability to handle multiple tasks concurrently, and in a timely fashion. Computer literate. Must be able to communicate effectively with supervisors and peers. Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion. Must be able to consistently demonstrate self-motivation and the ability to think independently. Maybe required to work flexible hours and overtime on short notice.

     

    Education and/or Experience:

     

    Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 year’s experience.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed