Welcome page Returning Candidate? Log back in! Quality Systems Specialist Job Locations US-PA-Philadelphia Job ID 2024-13289 Overview

Responsible for duties associated with two or more Quality System processes, including: the administration, reporting and process creation / optimization / automation, while ensuring accordance with current good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP) and current Good Tissue Practices (cGTP). The processes comprising the Quality Systems include: Non- conformance / Investigations, CAPA, Change Control, Customer Audits, Supplier Audits, Training, and Supplier Qualification Program. Duties include effectively interacting with Testing, Manufacturing, Project Management and Quality Assurance personnel in order to deliver superior customer service. Acts as a back-up for the Supervisor when needed

Responsibilities Administers assigned Quality Process. Duties include issuance of process tracking numbers and completion associated tasks according to established Standard Operating Procedures (SOP).Generates and maintains Quality data and associated metrics according to established SOPs.Reports Quality metrics according to established SOPs or by Management request.Leads team on improving assigned quality processes.Becomes the Subject Matter Expert (SME) for the assigned Quality processes.Authors and leads development / modification / improvement efforts associated with Quality SOPs.Ensures document maintenance is adhered to. (i.e.: biennial SOP reviews)Provides and prepares documentation and materials for/in various reporting forums for internal and external customers.Leads and/or participates in Quality System        reporting forums assessing compliance with cGMP and other applicable regulations.Participate/Lead in quality and process improvement initiatives, and project teams.Conducts internal and client audits.Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.Normally receives minimal instructions on routine work and detailed instructions on new assignments.Works under close supervision from supervisor or senior personnelAbility to work in a team environment and independently as requiredMaybe required to work Holidays and weekendsContributes to the overall operations and to the achievement of departmental goalsPerform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.Thorough understanding of Good Laboratory Practices and Good Manufacturing PracticesPerform other duties as assigned Qualifications

Experience / Education

3-5 years of relevant experience or equivalentBachelors’ degree in a Science related field or equivalent experience

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 ChemicalsMust be able to work in environment with variable noise levelsAbility to stand /Sit/walk for long periods of time

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.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

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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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