WuXi AppTec

  • Technical Operations Specialist I, Testing

    Job Locations US-PA-Philadelphia
    Job ID
    2018-3947
  • Overview

     Responsible for providing technical support to Testing Operations in the performance of activities that support Biosafety Testing.  The Technical Operations Specialist will generate and/or review testing related technical documents and manage timely closure of these documents. This includes but is not limited to Non-Conforming Event (NCE) investigations, Laboratory Investigations, CAPAs, and Standard Operating Procedures (SOP).

    Responsibilities

    • Participates, provides information in the development of and authors basic technical documents such as non-conforming events, laboratory investigations, deviations, CAPA’s, action plans and change controls
    • Execute NCEs and investigations ensuring complete and thorough review and timely closure
    • Understands aseptic technique concepts
    • Understands basic experimental designs for general laboratory methods such as PCR, Cell Culture, Virus Detection Techniques, and Analytical methods.
    • Able to identify unacceptable practices and implement improvements
    • Understands basic operations and functions of equipment
    • Understands basic solution and material preparation
    • Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry
    • Ideally, understands the application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of testing
    • Possess basic knowledge of Out of Specification Results and investgiations
    • Possesses basic and fundamental understanding of validation activities
    • Possesses basic and fundamental understanding of material related activities
    • Possesses some proficiency on Master Control
    • Possesses basic and fundamental understanding of support systems (e.g. LIMS)
    • Identifies, understands and able to explain the ‘why’ of acceptable and unacceptable practices, is able to make suggestions to improve performance
    • Performs basic analysis, interprets, and draws conclusion of scientific and process data per good document practices
    • Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations. 
    • Identifies, communicates, addresses and improves simple cGMP compliance and regulatory gaps and issues
    • Follows and executes Standard Operating Procedures (SOPs)
    • Revises, authors and provides comments as a reviewer to simple SOPs
    • Improves the efficiency and execution of SOPs
    • Improves the efficiency and right-first-time (RFT) of BR execution
    • Trains others on basic SOPs, equipment and unit operations
    • Trains others on basic Technical Operations SOPs and systems
    • Possess basic computer skills and able to efficiently use basic Microsoft applications
    • Suggests, participates and implements continuous improvement ideas
    • Identifies, participates, suggests solutions and leads basic technical problems
    • Identifies, participates, suggests with options,  recommends path forward and leads basic decision making
    • Participates, supports, presents and represents as an SME during regulatory inspections and client audits
    • Interacts frequently with groups
    • Regularly coordinates with groups
    • Cross trains in other areas and may be utilized to perform above job functions across the entire site
    • Performs well under minimal supervision and starts to work independently on basic tasks and processes
    • Ideally, possesses lean/six sigma knowledge and experience
    • May be required to work Holidays and weekends
    • May be required to work Overtime
    • May be required to work outside of normal business hours
    • 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:

     

    • Associates’/Bachelor’s (science preferred) degree with over 2 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.
    • Proficient in Oral & Written communication skills
    • 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
    • Proficient in Microsoft (Excel, Word, Outlook)

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled 

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