WuXi AppTec

  • Laboratory Technician II

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4509
  • Overview

    Responsible for performing assays and related activities within the testing facility to support manufacturing, as well as standard, and custom testing following cGMP Guidelines.

    Responsibilities

    • Performs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines, and SOPs using appropriate laboratory techniques for the lab group assigned to.
    • Performs laboratory support functions (e.g. materials stocking function) to help ensure lab is operational and contributes to the overall operations and to the achievement of departmental goals and objectives.
    • Adheres to and understands the importance of Good Manufacturing Practices and standard operating procedures, including Good Documentation Practices.
    • Performs basic Standard Operating Procedures (SOP’s) revisions and Reagent Preparation Records as needed to accurately reflect testing procedures.
    • Completes recording of data in instrument logbooks and lab cleaning forms to comply with regulatory requirements.
    • Attend daily lab meeting on a regular basis and escalate issues/concerns at that forum to the supervisor for further investigation.
    • Performs revisions to existing documents (e.g., BRs, RPs, SOPs) following the DCR process.
    • Provides operational support for testing activities including reagent preparation, cleaning activities, and equipment maintenance.
    • Supports technical transfer of assays from client to Technical Development to Operations; supports additional research level testing activities.
    • Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required.  Works with minimal supervision from supervisor or Technical Reviewer.
    • Completes all requisite site-specific and job-specific training (e.g, Bloodborne Pathogens, Safety, GDP,
    • Demonstrates technical knowledge and contributes to the overall operations.
    • Contributes to the achievement of departmental goals and objectives. 
    • Understands the importance of the regulatory compliance requirements for the production of biologics.
    • Authors Test Methods, Standard Operating Procedures (SOP’s) and Reagent Preparation Records as needed to accurately reflect manufacturing processes.
    • Ensures junior manufacturing personnel comply with standard operating procedures.
    • Works on routine assignments as well as other assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations.
    • Normally receives no instructions on routine work and general instructions on new assignments.
    • Works under minimal supervision from the area supervisor or area leader.
    • Serves to mentor junior staff.
    • Ability to work in a team environment and independently as required
    • Technician is required to work the assigned schedule
    • May be required to work Overtime.
    • Contributes to the overall operations and to the achievement of departmental goals
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
    • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
    • Other duties as assigned
    • May be required to assist in other departments

    Qualifications

    Experience / Education   

    • A minimum of 2 or more years of relevant experience or equivalent
    • Bachelors’ degree with a major in Biology, Chemistry or related Science major including lab courses involving work with nucleic acids.

     

    Knowledge / Skills / Abilities:

    • Experience in aseptic processing techniques a plus.
    • Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
    • Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
    • Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
    • Works in production environment with exposure to latex and bleach.  Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors. 
    • Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program. 
    • Proficient in Verbal & Written communication skills
    • Need to be able to read, write and understand English
    • Proficient in Microsoft (Excel, Word, Outlook)
    • No travel is required

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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