WuXi AppTec

Sterility Assurance Technical Writer II

Job Locations US-PA-Philadelphia
Job ID
2024-12750

Overview

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need. 

 

Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning. 

  

Our benefits include:

·      401K matching

·      PTO

·      Employee discount programs

·      Medical, dental and vision insurance

·      and much more.

 

This position is responsible for providing technical writing support to Sterility Assurance for excursions within a manufacturing GMP facility.  Perform root cause analysis to discover the main issue and how it can be resolved.

Responsibilities

  • Understands aseptic technique concepts
  • Able to identify unacceptable practices and implement improvements
  • Understands basic operations and functions of equipment
  • Understands the maintenance of equipment
  • Understands basic solution and material preparation
  • Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry
  • Possesses basic and fundamental environmental monitoring knowledge and is able to apply in the manufacturing area
  • Understands the application of GMP concepts and is able to recommend and identify improvements of sterility assurance
  • Possesses basic and fundamental understanding of material related activities
  • Possesses proficiency on Master Control
  • Possesses proficiency on Novatek
  • Understands the concept of manufacturing processes and methods
  • 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
  • Trains others on basic SOPs, equipment 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
  • 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
  • Performs well under minimal supervision and starts to work independently on basic tasks and processes
  • 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
  • Trending of EM data and writing summary trending reports
  • Reviews audit trails for EM monitoring and provides summary reports
  • Other duties as assigned

Qualifications

Experience / Education:

  • High school diploma and over 6 years of relevant experience or
  • Associates’/Bachelor's (science preferred) degree with over 3 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.
  • Holidays and shift work often required based on manufacturing schedule as determined by Management.
  • Proficient in Oral and Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

  • 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 Lift 40 lbs routinely/often/occasionally
  • Ability to crouch, bend, twist, and reach.
  • 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.

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