WuXi AppTec

Assistant Quality Assurance Specialist

US-NJ-Plainsboro
Job ID
2017-3325

Overview

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

Responsibilities

Primary Duties and Responsibilities:

  • Maintains a current awareness of EPA, FDA, and OECD Good Laboratory Practice (GLP) regulations and any other related Regulations which may apply to XBL activities.
  • Under guidance of senior QA personnel, 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 any GLP-regulated study performed at the laboratory for conformance to the final protocol, SOPs, and relevant GLP regulations.
  • Under guidance of senior QA personnel, prepares written records of all inspections and submits inspection reports to the study director and management, indicating deviations from or conformance with GLPs, protocols, and SOPs.
  • Reports periodically to supervisor regarding status of inspection/audit activities.
  • Assists in reviewing, writing, and maintaining up-to-date SOPs for QA unit and assists in the preparation of standard operating procedures.
  • Updates the master schedule.
  • Works closely with senior QA personnel in overall QA functions.
  • Other duties as assigned.

 

Qualifications

Experience / Training / Education:

  • Two year college A.S. degree in science or Bachelor’s degree in biology, chemistry, or related field preferred
  • 1-4 years of experience in QA or a related field
  • Familiarity with Good Laboratory Practice standards and experience working in a GLP/GMP regulated research environment is desirable
  • Any similar combination of education and experience

 

Knowledge / Skills / Abilities:

  • Knowledge of commonly used concepts, practices, and procedures within QA field
  • 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 XBL requirements

 We are an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled.

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