WuXi AppTec

  • Supervisor Manufacturing Support Services

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4217
  • Overview

    Responsible for providing supervision in the cleaning and sanitization of GMP space and associated areas that manufacture Master and Working Cell Banks, within production facilities that manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs)

    Responsibilities

     

    • Supervises, leads and oversees performance of associates in area of responsibility
    • Understands aseptic technique concepts and impact of the cleaning/sanitization program has on the GMP environment
    • Prepares and adjusts schedules, delegates and is accountable for area of responsibility
    • Trains, coaches and mentors associates within area of responsibility
    • Oversees the operation and maintenance of cleaning equipment
    • Oversees cleaning/sanitization solution and material preparation
    • Possess basic technical knowledge and background
    • Oversees the ordering, receipt, organization and inventory of cleaning/sanitization and gowning materials
    • Identifies and communicates material discrepancies
    • Understands the concept of manufacturing processes and methods
    • Oversees compliance to regulatory requirements and current Good Manufacturing Practices (cGMPs) of operations within scope of responsibility
    • Understands regulatory requirements and cGMPs within scope of responsibility and is able to communicate gaps, coach and mentor others
    • Addresses and improve complex compliance regulatory gaps/issues
    • Oversees execution of, follows and executes Standard Operating Procedures (SOPs)
    • Oversees execution of, follows and executes Batch Records (BRs)
    • Participates in the development of technical documents such as non-conforming events and deviations
    • Possess basic computer skills and able to efficiently use basic Microsoft applications
    • Suggests, participates, implements and leads continuous improvement efforts
    • Leads complex technical problem solving in area of responsibility
    • Makes complex decisions in area of responsibility
    • Participates on regulatory inspections and client audits
    • Regularly interacts, coordinates, and deals with problems in a cross functional manner with groups that support manufacturing and area of responsibility
    • Cross trains in other areas and may be utilized to perform above job functions across the entire site
    • May be required to work Holidays and weekends
    • 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       

    • High School diploma and over 8 years of relevant experience or
    • Associates’/Bachelor’s (science preferred) degree with over 5 years of relevant or equivalent experience

     

    Knowledge / Skills / Abilities:

    • 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. 
    • Holiday and shift work often required based on manufacturing schedule as determined by Management.
    • Proficient in Oral & Written communication skills
    • Need to be able to read, write and understand English (Mandarin)
    • Proficient in Microsoft (Excel, Word, Outlook)
    • Travel is required X% , Domestic/International, Daily / Overnight

     

    Physical Requirements:

    • Must be able to work in an office environment with minimal noise conditions.
    • Must be able to work in Lab setting with exposure to Animals/biohazards / Chemicals (List specific Chemicals)
    • Must be able to wear appropriate PPE
    • Must be able to work in environment with variable noise levels
    • Ability to stand /Sit/walk for long periods of time
    • Ability to Lift 40 lbs routinely
    • Ability to crouch, bend, twist, and reach
    • Ability to push/pull 40 lbs routinely/ often / occasionally
    • Clarity of Vision
    • Ability to identify and distinguish colors
    • Must be able to perform activities with repetitive motions
    • Ability to climb Ladders / Stairs / Scaffolding
    • Ability to work in variable temperatures high to freezing
    • Inside/outside working conditions

      Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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