Technical Operations Specialist I

Overview

This position is responsible for investigative writing, performing root cause analysis, developing appropriate corrective and preventative action for non-conformances and deviations while performing activities within supply chain.

Technical Operations Specialist will ensure that documents received from vendors and employees are consistent with all applicable quality procedures and policies. Additionally, the individual in this role will generate and/or review supply chain related technical documents and manage timely closure of these documents. This includes but is not limited to SOPs, Policies, Forms, Non-Conforming Event (NCE) investigations, Deviations, CAPAs and Change Controls (CC).

Responsibilities

• Execute NCE investigations ensuring complete and thorough review and timely closure (target <30 days from initiation)• Develop and maintain quality metrics around NCEs and CCs• Provide support in writing procedures, policies, SOPs, Forms, and work flows as needed to support supply chain operations• Evaluate trends in NCEs and recommend CAPAs• Work with appropriate departments for efficient management of NCEs• Works with vendor to understand and resolve issues• Contributes to validation activities and execution for supply chain• Involved with material management related activities and execution• Follows and executes Standard Operating Procedures (SOPs)• Subject Matter Expert (SME) on Master Control• Communicates department needs to other associated departments as required• Investigate alarms related to the logistics• Maintain positive effective relationships with vendors, coworkers and both internal and external customers• Identifies, participates, understands and able to explain the 'why' of acceptable and unacceptable practices; is able to make suggestions with options and recommend path forward and leads basic sessions to improve performance • Suggests, participates, implements and leads continuous improvement ideas• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands 'why' behind the regulations.

Qualifications

• High School diploma and at least 5 years of relevant or equivalent experience or Associate's/Bachelor's (Supply Chain preferred) degree with over 3 years of relevant experience

Knowledge / Skills / Abilities:• Proficient in Oral & Written communication skills• ERP Knowledge• Need to be able to read, write and understand English • Proficient in Microsoft (Excel, Word, Outlook)

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec 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.