Quality Assurance Materials Specialist I - WuXi AppTec

Main function is to release raw materials intended for Manufacturing and Testing Operations according to site policies and procedures. Assists in the preparation of Standard Operating Procedures (SOPs). Review and approve deviations and low-risk non-conforming events (NCEs). Lead and implement continuous improvement. 

• Reviews all receiving documentation provided by Logistics for conformance to Specifications.
• Assures that correct product labels have been generated by Logistics
• Confirms accuracy of information entered by Logistics into inventory management system in order to perform disposition
• Reviews inspection and testing data and provides disposition of materials after all release criteria have been evaluated.
• Evaluates the need for sampling/inspection of material  Files and distributes certificates of analysis as required.  Scans completed quality documentation into controlled locations  Participates directly in audits of assigned areas.
• Inspects in-house areas, discusses conditions/practices with appropriate personnel, documents and reports findings to Management and follows-up as needed.
• Provide quality input into investigational and CAPA tasks
• Participate in quality and process improvement initiatives, and project teams
• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.)
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required
• Ability to work in a team environment and independently as required
• May be required to work Holidays and weekends
• Contributes to the overall achievement of departmental goals.
• Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Thorough understanding of Good Manufacturing Practices.
• Performs other duties as assigned.

Experience / Education 

• 3 -5 years of relevant experience or equivalent
• High School diploma or equivalent required

Knowledge / Skills / Abilities:

• Ability to accomplish the described duties through the use of appropriate computer equipment and software (especially Microsoft Word, Excel, and Outlook).
• Must be proficient in multitasking and time management.
• Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
• Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
• Ability to use judgment as dictated by complexity of situation
• Proficient in Oral & Written communication skills

Physical Requirements:

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with Biohazards /various Chemicals 
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time
• Ability to Lift 20 lbs routinely
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 20 lbs routinely/ often / occasionally
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions  Ability to work in variable temperatures high to freezing

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.