Quality Systems Specialist
WuXi AppTec - Philadelphia, PA
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The Quality Systems (QS) Specialist serves as a key resource for providing oversight and guidance to ensuring compliance with site operations, policies, procedures, processes to ensure improvements to mitigate process and/ or product risks at WuXi AppTec. This position will support multiple aspects within the Quality organization with focus on but not limited to; supplier quality functions, complaints, SOP writing and review, Quality event review, and auditing support.Support/host internal, external audits and regulatory inspections. Fulfills records requests as part of audit support. Contribute to the writing, coordination, review, approval and maintenance of Policies and Standard Operating Procedures (SOPs).Support and train cross functional groups with guidance on deviation management to ensure accurate reporting, investigation, root cause analysis and corrective actions.Back up resource for training quality compliance systems (i.e. MasterControl, NonConformances (NCE), Deviations, Complaints, Supplier Program, and Change Control).Assists with document control activities including Quality (QA) approval of documentsAssists with supplier qualification activities including management of the approved supplier list, reviewing Supplier Corrective Action Reports (SCARs), and qualifying suppliers for use.Provide QA input to functional groups to evaluate and ensure proper closure of deviations, investigations, and complaints.Ability to work in a team environment and independently.Contributes 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 PracticesOther duties as assigned May be required to assist in other departmentsExperience / EducationPreferred 2 years of experience in medical device or other regulated industry.Bachelor’s or Associate’s degree preferable in Business or Science. Preferred GLP, ISO 13485 or ISO 17025 auditor trainingKnowledge / Skills / Abilities:Demonstrated knowledge of Quality AssuranceExcellent verbal and written communication and interpersonal skills. Ability to work collaboratively across all functional groups and all levels.Highly motivated, goal-oriented achiever with ability to prioritize and organize own work independentlyExcellent problem-solving skillsExperience working with Electronic Document Management systemsComputer skills; working knowledge of Internet, MS Excel, Word, Outlook Physical Requirements:Must be able to work in an office environment with minimal noise conditions.Must be able to work in a setting that may have exposure to animals/biohazards/chemicals.Ability to stand /Sit/walk for long periods of time Must be able to wear appropriate PPE when requiredInside working conditionsAn 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 disabilityThis 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.
Created: 2024-09-07