WuXi AppTec • Philadelphia, PA 19133
Job #2697061079
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.
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)
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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Job Locations US-PA-Philadelphia
Job ID 2024-12750
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