Welcome page Returning Candidate? Log back in! Quality Assurance Materials Specialist I Job Locations US-PA-Philadelphia Job ID 2024-13157 Overview

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. 

Responsibilities Reviews all receiving documentation provided by Logistics for conformance to Specifications.Assures that correct product labels have been generated by LogisticsConfirms accuracy of information entered by Logistics into inventory management system in order to perform dispositionReviews 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 tasksParticipate in quality and process improvement initiatives, and project teamsStay 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 requiredAbility to work in a team environment and independently as requiredMay be required to work Holidays and weekendsContributes 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. Qualifications

Experience / Education 

3 -5 years of relevant experience or equivalentHigh 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 situationProficient 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 PPEMust be able to work in environment with variable noise levelsAbility to stand /Sit/walk for long periods of timeAbility to Lift 20 lbs routinelyAbility to crouch, bend, twist, and reachAbility to push/pull 20 lbs routinely/ often / occasionallyClarity of VisionAbility to identify and distinguish colorsMust 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.

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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
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