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Sterility Assurance Technical Writer II

Company: WuXi AppTec
Location: Philadelphia
Posted on: September 17, 2023

Job Description:

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. Ensures that all equipment is properly monitored by the EMS system were required.

  • 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.
  • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
  • Ability to work in a team environment and independently as required.
  • Other duties as assigned.
  • May be required to assist in other departments.
  • 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
    • 1-3 years of relevant experience or equivalent.
    • Associates' degree with a major in a technical discipline or equivalent experience.
    • Excellent verbal and written skills
    • Experience in investigation writing complex reports, studies and/or scientific a regulated environment, GMP, GDP, 21CFR210 &211
    • 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.--- Must be able to work in an office environment with minimal noise conditions.
    • Must be able to work in Lab setting with Biohazards / various 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 crouch, bend, twist, and reach.
    • Clarity of Vision.
    • 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.

Keywords: WuXi AppTec, Philadelphia , Sterility Assurance Technical Writer II, Engineering , Philadelphia, Pennsylvania

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