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 Associate Quality Assurance Specialist for their QA Department located in Plainsboro, NJ.
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.
Evaluates current laboratory practices. Recommends changes or modifications to laboratory procedures in order to facilitate compliance with GLP standards.
Conducts audits (protocol/plan, raw data, and final report audits for accuracy and completeness, verifying that the final reports accurately reflect the raw data generated) and in-lab critical phase inspections of any GLP-regulated study performed at the laboratory for conformance to the final protocol/plan, SOPs, and relevant GLP regulations.
Conducts inspections of laboratories/facilities
Conducts audits of employee training files.
Prepares written records of all inspections and audits. Submits findings to the study director,and/or principal investigator (or laboratory supervisor, when appropriate) and management, indicating deviations from or conformance with GLPs, protocol/plan, methods and SOPs.
Reports periodically to QA management regarding quality issues and status of inspection/audit activities.
Assists in reviewing, writing, and maintaining up-to-date SOPs and controlled documents for the QA unit.
Updates the master schedule as required by GLPs.
Other duties as assigned by QA management
Experience / Training / Education:
Bachelor's degree in biology, chemistry, or related field.
At least 2 years of experience in QA or QC, with focus on bioanalytical
Familiarity with Good Laboratory Practice standards and experience working in a GLP regulated research environment.
Any equivalent combination of education and experience
Knowledge / Skills / Abilities:
Knowledge of EPA, FDA, and OECD Good Laboratory Practice (GLP) regulations and commonly used concepts, practices, and procedures within GLP 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, SharePoint 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
Equal Opportunity Employer Minorities/Women/Veterans/Disabled