Hikma Pharmaceuticals USA Inc.

  • QA Inspector-QA

    Job Location US-NJ-Cherry Hill
    Posted Date 4 weeks ago(10/18/2018 6:06 PM)
    Job ID
    2018-4853
    Job Function
    Quality
  • Overview

    This position is located in Cherry Hill, NJ and is a 2nd shift position.

     

    The QA Inspector monitors in-process product quality for Filling and Inspection and Packaging of parenteral products. The QA Inspector is responsible for performing visual and functional testing of product against statistically based sampling plans. In addition, the QA Inspector performs routine inspection and testing of components in accordance with Standard Procedures and specifications as required by production scheduling. In performing the above duties, the individual is responsible for accurately and clearly documenting test results in accordance with cGMPs. This position participates in rotation for weekend coverage and as needed during the work week.

    Responsibilities

    1. Performs in-process monitoring (Filling room, Inspection/packaging lines, Oxygen headspace testing and Osmolality testing).
    2. Contacts QA Coordinator or QA Supervisor for daily line assignments and in response to OOS results and manufacturing deviations.
    3. May perform routine inspection and testing of components.
    4. Samples/Checks/Verifies Controlled Substances during in-process monitoring.
    5. Prepares and /or issues Batch record documents when needed.
    6. Test filled units using analytical instrumentation such as Analytical balances and Gas Chromatograph.
    7. Maintains good housekeeping and safe working conditions.
    8. Accurately and clearly documents inspection/test results in accordance to department and site SOPs.
    9. Performs other duties to support production or validation as determined by QA Supervisor.
    10. Participates in rotation for weekend coverage to support production. May work flexible hours and overtime on a short notice to support production.
    11. Uses laboratory instrumentation, syringes, reagents and compressed gases on a daily basis.

    Qualifications

    Bachelors degree in Science or equivalent with 0-2 year applicable laboratory, pharmaceutical manufacturing or related experience (QA preferred).

     

    1. Minimum 3 year applicable laboratory or pharmaceutical production experience (QA preferred).
    2. Possesses proficient mathematical skills (addition, subtraction, multiplication, division, algebra, unit conversions, rounding significant figures, dividing polynomials, solving rational equations).
    3. Familiar with cGMPs, EU, CFR and the USP.
    4. Demonstrates good attention to detail and accuracy.
    5. Good organizational skills and ability to multi-task and perform work in a timely manner.
    6. Demonstrates ability to work in a team environment with good communication skills and ability to communicate effectively with peers, department management and production personnel.
    7. Knowledge of computer systems at a level proficient to navigate input and/or reference computerized data.
    8. Must have sound judgment and demonstrate good analytical skills to assess risk to issues related to the manufacturing process.
    9. Must be able to pass the vision requirements established for the Inspector position.

    Physical Demands

    1. Ability to walk from line to line 85% of the shift.
    2. Good manual dexterity to repetitively manipulate syringes to sample filled units for in-process monitoring.
    3. Good close visual acuity (eye exam required).
    4. Noise levels on production lines may be moderate to high
    5. Able to lift 15 lbs.

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