Associate Quality Assurance Specialist
- 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
- 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
Job Function: Research & Development
Primary Location: Plainsboro NJ
Please contact Jennifer.Royal@wuxiapptec.com for more information about this position
If you are interested in learning more about the opportunities, please visit our website: https://careers-wuxiapptec.icims.com/jobs