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    Manufacturing Associate-Nights - Wilmington, United States - Alkermes, Inc.

    Alkermes, Inc.
    Alkermes, Inc. Wilmington, United States

    3 weeks ago

    Default job background
    OTHER
    Description

    Summary:

    Perform all necessary operation activities in bulk manufacturing. These activities include but are not limited to the following: Equipment Cleaning, Equipment Set-up, Equipment/Automation Operation, and Batch Processing. Reads and follows detailed written SOPs / Procedures and detailed documentation of operations according to cGMP. Performs sample collection, equipment/process monitoring, and minor maintenance. Maintain individual training proficiency through individual Learning Management System. Other responsibilities include SOP writing and review of cGMP documentation

    Job Description:

    • Read and follow detailed written SOPs / Procedures
    • Document all work as required by cGMPs on a timely basis
    • Executes tasks as directed with close attention to detail
    • Monitors Process with close attention to detail
    • Abide by all safety requirements as defined by the company
    • Can work independently without constant supervision
    • Follows Alkermes internal policies
    • Works well in a team environment
    • Perform facility / equipment cleaning and set-up
    • Assist with Development activities and Validation as required
    • Other tasks as assigned by Manager
    • Shift coverage and weekend work may be required

    Minimum Education & Experience Requirements:

    Manufacturing Associate I

    Basic Requirements

    • High School diploma or equivalent.

    Preferred Requirements

    • 0-1 year experience in a sterile pharmaceutical operation preferred.
    • Associates degree or higher in ascience/technical discipline

    Manufacturing Associate II

    Basic Qualifications:

    • High School Diploma or equivalent
    • 1-3 year of pharmaceutical manufacturingor equivalent experience.

    Preferred Qualifications:

    • 1+ year experience in a sterile pharmaceutical operation
    • Associates degree or higher in ascience/technical discipline

    Manufacturing Associate III

    Required Education and Experience

    • High School diploma or equivalent.
    • 4-5 years' experience in pharmaceutical Manufacturing

    Preferred Education and Experience

    • 2-3 years' experience in a sterile pharmaceutical operation
    • Associates degree or higher in ascience/technical discipline

    Knowledge/Skills Needed:

    • General math skills, including simple algebra
    • General knowledge of and adherence to Current Good Manufacturing Practices
    • General knowledge of HAZCOM, RCRA, and other Safety requirements
    • Good level of mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment
    • General computer word processing/spreadsheet skills
    • Good written communication
    • Excellent documentation skills
    • Ability to lift / move 50lbs. overhead. Ability to team lift 100 lbs
    • Ability to operate all types of production equipment (i.e. Rockwell HMI, CIP system, etc.)
    • Ability to gown for clean room operations
    • Ability to read, understand, and accurately follow company SOPs and guidelines

    #LI-AH1

    PDN-9bdf6f64-fff2-430d-b3b b9
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