WuXi AppTec

  • Manufacturing Operations Compliance Specialist I

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4343
  • Overview

    Responsible for providing compliance support to the manufacture of Master and Working Cell Banks and performing activities within production facilities to
    support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

    Responsibilities

    • 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
    • Improves the efficiency and execution of SOPs and right first time of batch record
      execution.
    • Trains others on basic SOPs, equipment, systems and unit operations
    • Participates, provides information in the development of and authors basic
      technical documents such as non-conforming events, deviations, CAPA’s, action
      plans and change controls
    • Suggests, participates and implements continuous improvement ideas
    • Identifies, participates, suggests solutions and leads basic technical problems
    • Aid Manufacturing to continuously improve and install “permanent inspection
      readiness” mindset, culture, operation, processes and systems
    • Support, coach, guide, teach and assess the Manufacturing facility, equipment,
      documents, processes, systems and people for audits and inspections
    • Prepares, coordinates, manages, participates, supports, presents and represents
      as an SME during regulatory inspections and client audits
    • Interface with Manufacturing, QA, Support Functions and auditors/inspectors,
      during audits and inspections. Activities may include presence or presenting in
      the front room, preparing SMEs or presenters and representing or acting as the
      MFG lead in the backroom
    • Support coordination and response for MFG and related area audit and
      inspection responses in a satisfactory and timely manner
    • Support closure of CAPAs resulting from audits and inspections
    • Support, coordinate and manage prospective and current non-audit client tours
    • Communicate with clients on compliance issues and corrective actions
      surrounding PHL audits.
    • Assume a contributing role in compliance projects
    • Support and prepare metrics/KPIs as a means to drive improvement of
      performance
    • Interacts frequently with groups
    • Regularly coordinates with groups
    • 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
    • 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 4 years of relevant experience or
    • Associates’/Bachelor’s (science preferred) degree with over 2 years of relevant or
      equivalent experience


    Knowledge / Skills / Abilities:

     

    • Understands aseptic technique concepts
    • Able to identify unacceptable practices and implement improvements
    • Understands basic operations and functions of equipment
    • Possesses basic technical knowledge and background in the pharmaceutical and
      biotechnology industry
    • Ability to accurately and reproducibly perform arithmetic calculations including
      fractions, decimals and percentages and basic algebraic and geometric
      calculations.
    • Based on work assignment, may be recommended to have medical testing in
      accordance with the company’s Occupational Health Program.

      Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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