Integra LifeSciences

  • Lead Associate, 2nd Shift

    Vacancy ID
    2018-28434
    Location
    US-NJ-Plainsboro
    Position Type
    Regular Full-Time
    Category
    Manufacturing
  • Overview

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    Responsibilities

    Provide daily direction to the manufacturing floor based on production schedule, available resources and department priorities. Engage and support manufacturing process to assure timely completion and quality throughput. Lead and support administrative activities such as training, investigations, procedure development and inventory management within the manufacturing area. Drive a positive culture within the manufacturing environment through teamwork, engagement and respect.

     

    People

    • Allocate resources to meet daily schedule needs and support recover plan development and execution
    • Partner with area management to identify overtime needs in advance
    • Communicate with support groups to on daily processing needs
    • Provide feedback to department management on operator and process performance
    • Interface with support departments to establish clear/consistent manufacturing objectives and need

    Process

    • Perform all requirements of a Manufacturing Operator
    • Provide daily oversight of manufacturing operations in the suite
    • Actively engage in all areas of the manufacturing process
    • Identify and resolve training gaps (process, performance, paperwork) through the execution of a training plan
    • Own operator training for all new Manufacturing Operators
    • Lead troubleshooting initiatives to minimize equipment/process downtime
    • Perform manufacturing suite walk through activities to identify equipment deficiencies and observe operator execution
    • Support investigations as a subject matter expert
    • Maintain process and component inventories
    • Support time management around start/stop, breaks and timely completion of tasks

     

    Paperwork

    • Obtain batch records in advance for associated manufacturing operations to prevent delays
    • Document manufacturing activities in real time and perform daily in-process checks of paperwork
    • Supply and receive paperwork from support groups when necessary to keep manufacturing operations on track and progressive
    • Provide comments in batch records not limited to non-conformance references or other clarifications
    • Perform daily, in-process reviews of batch records to support good documentation practices
    • Develop, redline or review associated manufacturing documentation

    Qualifications

    • High School diploma or equivalent. Degree in related science a plus.
    • 1-3 years’ experience in a manufacturing environment in the Medical Device or Pharmaceutical industry.
    • Basic computer skills for email and data entry.
    • Must read, write and speak in English, and communicate clearly and concisely.
    • Able to participate in a team-oriented environment, willingness to assist and train others
    • Able to work independently with minimal supervision
    • Able to work overtime
    • Ability to operate, maintain and troubleshoot process equipment, and make minor adjustments as needed.
    • Ability to gown to ISO Class 5 and 7 Clean Room standards.

    TOOLS AND EQUIPMENT USED

    Lyophilizers, Autoclave, homogenizers, grinder, vacuum pump, pH meters, thermometers, balances (scales), water bath circulators, sonicators, humidity cabinet, mixers, centrifuge, blenders, air gun, drop indicator, Filamatic filling machines, slicer machines, scalpels, temperature recorders, Crosslinking chamber, humidification chamber, compression unit, cutting table, sealing machines, shrink wrap machines.

     

    PHYSICAL REQUIREMENTS

     

    The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

     

    While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write/type. The employee must be able to stand for 8 hours, lift up to 60lbs and climb ladders without assistance. The employee is required to go to all areas of the company.

     

    Must be able to bend and lift 30 to 60 lbs without assistance on a daily basis.

    Ability to gown to ISO Class 5 type Clean Room standards and/or additional Clean room clothing

    Ability to gown to ISO Class 7 type Clean Room standards and/or additional Clean room clothing

    Ability to stand for 8 hours

    Must be able to climb step ladders, without assistance

    Vision: Requires eye sight correctable to 20/25 to detect any defect in product/materials. Visual acuity adequate to perform job duties, including meeting all of the quality reclassification. Requires normal color perception.

     

    ADVERSE WORKING CONDITIONS  

    Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.

    The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

    Daily interaction with hazardous materials used in a controlled environment.

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