Sterility Assurance Technical Writer II
WuXi AppTec
Welcome page Returning Candidate? Log back in! Sterility Assurance Technical Writer II Job Locations US-PA-Philadelphia Job ID 2025-13603 Overview
biotechnology industryPossesses basic and fundamental environmental monitoring knowledge and is
able to apply in the manufacturing areaUnderstands the application of GMP concepts and is able to recommend and
identify improvements of sterility assurancePossesses basic and fundamental understanding of material related activitiesPossesses proficiency on Master ControlPossesses proficiency on NovatekUnderstands the concept of manufacturing processes and methodsIdentifies, understands and able to explain the ‘why’ of acceptable and
unacceptable practices, is able to make suggestions to improve performancePerforms basic analysis, interprets, and draws conclusion of scientific and process
data per good document practicesFollows 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 issuesFollows and executes Standard Operating Procedures (SOPs)Revises, authors and provides comments as a reviewer to simple SOPsImproves the efficiency and execution of SOPTrains others on basic SOPs, equipment and unit operationsParticipates, provides information in the development of and authors basic technical documents such as non-conforming events, deviations, CAPA’s, action plans and change controlsPossess basic computer skills and able to efficiently use basic Microsoft applicationsSuggests, participates and implements continuous improvement ideasIdentifies, participates, suggests solutions and leads basic technical problemsIdentifies, participates, suggests with options, recommends path forward and leads basic decision makingParticipates, supports, presents and represents as an SME during regulatoryinspections and client auditsInteracts frequently with groupsRegularly coordinates with groupsPerforms well under minimal supervision and starts to work independently on basic tasks and processes Qualifications High School diploma and over 6 years of relevant experience orAssociates’/Bachelor’s (science preferred) degree with over 3 years of relevant
or equivalent experience
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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 conceptsAble to identify unacceptable practices and implement improvementsUnderstands basic operations and functions of equipmentUnderstands the maintenance of equipmentUnderstands basic solution and material preparationPossesses basic technical knowledge and background in the pharmaceutical and
biotechnology industryPossesses basic and fundamental environmental monitoring knowledge and is
able to apply in the manufacturing areaUnderstands the application of GMP concepts and is able to recommend and
identify improvements of sterility assurancePossesses basic and fundamental understanding of material related activitiesPossesses proficiency on Master ControlPossesses proficiency on NovatekUnderstands the concept of manufacturing processes and methodsIdentifies, understands and able to explain the ‘why’ of acceptable and
unacceptable practices, is able to make suggestions to improve performancePerforms basic analysis, interprets, and draws conclusion of scientific and process
data per good document practicesFollows 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 issuesFollows and executes Standard Operating Procedures (SOPs)Revises, authors and provides comments as a reviewer to simple SOPsImproves the efficiency and execution of SOPTrains others on basic SOPs, equipment and unit operationsParticipates, provides information in the development of and authors basic technical documents such as non-conforming events, deviations, CAPA’s, action plans and change controlsPossess basic computer skills and able to efficiently use basic Microsoft applicationsSuggests, participates and implements continuous improvement ideasIdentifies, participates, suggests solutions and leads basic technical problemsIdentifies, participates, suggests with options, recommends path forward and leads basic decision makingParticipates, supports, presents and represents as an SME during regulatoryinspections and client auditsInteracts frequently with groupsRegularly coordinates with groupsPerforms well under minimal supervision and starts to work independently on basic tasks and processes Qualifications High School diploma and over 6 years of relevant experience orAssociates’/Bachelor’s (science preferred) degree with over 3 years of relevant
or equivalent experience
Advanced Therapies, LLC provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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