WuXi AppTec Technical Operations Specialist - Manufacturing in Philadelphia, Pennsylvania
Manufacturing Operations Investgator will generate and/or review Manufacturing related technical documents and manage timely closure of these documents. This includes but is not limited to Non-Conforming Event (NCE) investigations, CAPAs, Change Controls (CC), Batch Records (BR), Technical Transfers (TT), Final Reports (FR), and Standard Operating Procedures (SOP).
Execute NCE investigations ensuring complete and thorough review and timely closure (target <30 days from initiation).
Manage changes having GXP impact including process, equipment, and facility changes through WuXi’s Change Control process.
Maintain quality metrics around NCEs and Change Controls.
Evaluate trends in NCEs and recommend CAPAs.
Provide support writing BRs, TTs, FRs, and SOPs as needed.
Work with appropriate departments for efficient management of NCEs and CCs. This includes QA, Metrology, Validation, Facilities, and Manufacturing.
High School diploma and at least 4 years in cell production/biologics facility or Bachelor’s degree in Biology or similar and 2 years of experience in cell production/biologics facility or equivalent.
Experience executing Change Controls and performing NCE investigations in a GMP manufacturing environment and generating reports to high quality standards.
Technical writing skills specific to Cell Processing-related SOPs/MBRs a plus.
We are an Equal Opportunity Employer - Woman/Minorities/Disabled/Veterans
Job ID: 2017-2803
External Company Name: WuXi AppTec Inc
External Company URL: http://wuxiapptec.com