Join WuXi AppTec as a Technical Operations Specialist I, where you'll play a crucial role in generating and reviewing technical manufacturing documents in a dynamic, innovative environment. Contribute to advancing life-saving therapies while enjoying a collaborative culture and comprehensive benefits.
Key Responsibilities
Generate and review manufacturing-related technical documents
Manage timely closure of Non-Conforming Event (NCE) investigations, CAPAs, Change Controls (CC), Batch Records (BR), Technical Transfers (TT), Final Reports (FR), and Standard Operating Procedures (SOP)
Understand and implement aseptic technique concepts
Train and mentor others on SOPs, equipment, and unit operations
Participate in the development and authoring of technical documents
Follow compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs)
Required Qualifications
High School diploma and over 2 years of relevant experience
Associates/Bachelor’s degree (science preferred) with 1 year of relevant or equivalent experience
Ability to perform arithmetic calculations including fractions, decimals, and percentages
Proficient in Oral & Written communication skills in English
Proficient in Microsoft Office (Excel, Word, Outlook)
Preferred Qualifications
Technical knowledge and background in the pharmaceutical and biotechnology industry
Basic/fundamental and working application of engineering and mechanical knowledge
Basic and fundamental facility start-up experience
Lean/Six Sigma knowledge and experience
Benefits & Perks
401K matchingPTOEmployee discount programsMedical, dental and vision insurance