Lupin Pharmaceuticals (Company Headquarters)

  • Overnight Quality Assurance Technician

    Posted Date 3 weeks ago(10/29/2018 5:13 PM)
    ID
    2017-2056
    # of Openings
    1
    Category
    Quality Assurance
  • Overview

    Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions.  Together these entities make up the generic and branded U.S. business.  Lupin has a significant generic pipeline, and a branded focus on women’s health.  Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams.  Lupin is prided on being people-focused and centered around how impactful we are with our customers.  Dollars are not a measure of success but rather the people we help along the way.

     

     

    Responsibilities

    The Quality Assurance Technician is responsible for the assurance of proper GMP activities within the Lupin Somerset manufacturing and packaging facilities. This position is responsible for working in production, warehouse, process rooms and packaging lines to evaluate all manufacturing activities meet the acceptance criteria. Third shift is 11pm to 7:15am.

    • Sample, inspect incoming raw materials, in-process intermediates and purchased finished products and submits samples to the Quality Control laboratory for analysis.
    • Label the material status from Quarantine from Release to Reject and vice versa.
    • Monitor the manufacturing equipment and rooms and packaging lines/ equipment for cleanliness and approve them prior to the start of the operation
    • Perform Quality Assurance in-process checks (Beginning, Middle and End) for manufacturing and packaging operations and determine the results meets against pre-determined standards and batch record requirements.
    • Conduct Acceptable Quality Limit inspections on finished dosage forms against pre-determined Quality Attributes.
    • Collect and maintain Quality Assurance Retain samples from all products manufactured. Assure that all retains are stored in an appropriate manner for accountability, annual inspection and retrieval.
    • Sample and proofread all pharmaceutical labeling for conformance to the standard. Issues approved labels to the packaging lines for use.
    • Inform immediately any manufacturing/packaging issue to the Quality Assurance supervisor.

    Qualifications

     

    Education

    • Associate Degree or Bachelor’s Degree in a scientific field is preferred

     

    Skills

    • 3+ years' experience in a Quality Assurance role in the pharmaceutical industry
    • Knowledge of the pharmaceutical manufacuting and/or packaging process
    • Excellent communication skills
    • Attention to detail is paramount
    • Desire to acheive high quality of work and diligent about following Standard Operating Procedures
    • Knowledge of Good Manufacturing Practices

     

    Physical and Environmental Conditions

    The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing.   In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. In general the activity level one usually performs is light physical activity performing non-strenuous daily activities of an administrative and sedentary nature. This position may require lifting up to 25 pounds occasionally.   Generally work is performed in a manufacturing or warehouse environment.

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