Quality Assurance Specialist Job Locations US-NJ-Plainsboro Job ID 2018-4634 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 a Quality Assurance Specialist for their QA Department located in Plainsboro, NJ. Responsibilities Job Summary: The Quality Assurance Specialist will have the responsibility of monitoring regulated study-specific and facility-related data/records/files via inspections and audits. Additional responsibilities may also include assisting with sponsor and regulatory inspections, training/peer-reviewing QAU auditors and training technical staff, as assigned. Qualifications Essential Job Functions: Maintains a current awareness of EPA, FDA, and OECD Good Laboratory Practice (GLP) and related Regulations as they may apply to WuXi AppTec NEJ activities. Evaluates current laboratory practices. Recommends changes or modifications to facility and laboratory procedures that will maintain the facility compliance with current agency standards and regulations. Monitors laboratory studies that are conducted in accordance with applicable Regulations as they may apply to WuXi AppTec NEJ activities. 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 the final protocol, SOPs, and relevant GLP regulations. Maintains written records of all inspections and submits an inspection report to the study director and management, indicating deviations from or conformance with GLPs, protocols, and 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 helps maintain the master schedule. Assist with 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. Other duties, as assigned. Job Requirements: Experience / Education Bachelors degree in biology, chemistry, or related field At least 3 years of Quality Assurance experience preferred Familiarity with Good Laboratory Practice standards and experience working in a GLP 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 Effective oral and written communication skills Excellent interpersonal skills 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 Must be able to record and keep essential records for a regulated environment Familiarity with and adherence to regulatory guidelines consistent with WuXi AppTec NEJ requirements Physical Requirements: Must be able to work in an office environment Must be able to work in laboratory setting with exposure to biohazards Must be able to wear appropriate personal protective equipment (PPE) Must be able to work in environments with variable noise levels Must have the ability to stand /sit/walk for extended periods of time Must have the ability to lift/push/pull 10 lbs occasionally Must have the ability to identify and distinguish colors Must have the ability to work in indoors/outdoors at variable temperatures 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.