WuXi AppTec

  • Senior Quality Assurance Specialist

    Job Locations US-NJ-Plainsboro
    Job ID
    2018-4258
  • Overview

    Xenobiotic Laboratories (XBL), a subsidiary of the Lab Testing Division of WuXi AppTec, Inc., is a leading contract research laboratory specializing in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries.  XBL is seeking an Senior Quality Assurance Specialist for their QA Department located in Plainsboro, NJ. 

    Responsibilities

     

    • Maintains a current awareness of EPA, FDA, and OECD Good Laboratory Practice (GLP) and related Regulations as they may apply to XBL activities.
    • Monitors study conduct, study set-up, sample collection, and analysis for applicable Regulatory compliance including assurance that laboratories are run according to regulatory requirements.
    • Assists in the development and implementation of updates to the Company GLP program for adherence to FDA, EPA, OECD, and any other related applicable Regulations within the facility.
    • Evaluates current laboratory practices. Recommends changes or modifications to facilities and laboratory procedures that will maintain the facility compliance with current agency standards and regulations.
    • Monitors GLP off-site studies.
    • Conducts audits (protocol, raw data, and final report audits for accuracy and completeness, verifying that the final reports accurately reflect the raw data generated) and critical phase inspections of each GLP-regulated study performed at the laboratory for conformance to final protocol, SOPs, and relevant GLP regulations.
    • Maintains written records of all inspections and submits to the study director and management an inspection report, indicating deviations from or conformance to GLP, protocols, or SOPs.
    • Reviews, writes, and maintains up-to-date SOPs for QA unit and assists in the updates of standard operating procedures.
    • Conducts GLP training programs for technical laboratory personnel.
    • Updates and maintains master schedule.
    • Assists with arranging, scheduling, and assisting sponsors’ Quality Assurance inspections and regulatory agency inspections.
    • Serves in advisory capacity to other personnel within the company in providing assistance in Good Laboratory Practices.
    • Serve as mentor to junior personnel in QA department.
    • Other duties as assigned.

     

     

    Qualifications

     

    Experience / Training / Education:

    • Bachelor’s degree in biology, chemistry, or related field
    • At least 5 years of Quality Assurance experience is preferred
    • Familiarity with Good Laboratory Practice standards and experience working in a GLP/GMP regulated research environment
    • Any similar combination of education and experience

     

    Knowledge / Skills / Abilities:

    • Knowledge of commonly used concepts, practices, and procedures within QA field
    • Thorough understanding of Good Laboratory Practices and/or other regulatory guidelines applicable to EPA/FDA/OECD regulations
    • Must work well with numbers
    • Detail-oriented and highly organized
    • Computer skills: working knowledge of Internet, MS Word, Excel, Outlook, and PowerPoint
    • Ability to multitask and work under pressure of multiple projects and deadlines
    • Ability to effectively prioritize workload and manage changes in direction
    • Ability to work effectively in a multitasking environment; ability to communicate effectively with a highly diversified group of scientists, managers, and QA personnel
    • Must be able to record and keep essential records for a regulated environment
    • Familiarity with and adherence to regulatory guidelines consistent with XBL requirements

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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