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Associate Quality Assurance Specialist

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.
  • 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

Qualifications

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



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