WuXi AppTec

  • Sterility Assurance Technical Writer

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4316
  • Overview

    This position is responsible for investigative writing, performing root cause analysis, developing appropriate corrective and preventative action for deviations, developing protocols for qualification of sterility levels, and periodic reporting for microbiology and sterility assurance. Additional responsibilities include ownership of change controls, laboratory protocols, and providing a technical resource for topics around microbiology and process improvements.

    Responsibilities

    • As author of investigations, gathers information from internal and external sources in order to evaluate the impact of the occurrence, risk to future processes, root cause analysis, CAPA determination and effectiveness.
    • Works cross-functionally in identifying opportunities for continuous improvements.
    • Documents appropriate corrective/preventative actions designed to mitigate quality deficiencies.
    • Works independently and with management to assure compliance with procedural requirements.
    • Demonstrates technical skills and solves complex problems.
    • Responsible for working  with internal teams to assure that action items are investigated, monitored and tracked in an electronic system ensuring that plans address root cause and tasks are executed in a timely manner.
    • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
    • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
    • Works independently with minimal instruction.
    • 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.
    • Maintains a thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.

     

    Qualifications

    Experience / Education   

    • 1-2 years’ experience in investigation writing complex reports, studies and/or scientific protocols.in a regulated environment, GMP, GDP, 21CFR210 &211
    • BS Degree in the Life Sciences

     

    Knowledge / Skills / Abilities:

    • Excellent verbal and written skills
    • Ability to receive, comprehend and effectively communicate detailed information both verbal and written.
    • Ability to record data accurately and legibly
    • Ability to work as part of a team and exhibit effective interpersonal skills.
    • Uses professional concepts and applies company policies and procedures to resolve routine and complex issues.
    • Knowledge of cGMP requirements.
    • Follows standard practices and procedures in analyzing situations or data from which solutions can be readily obtained.
    • 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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