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