Associate Quality Systems SpecialistTravaillez avec un but précis

The Microbial Solutions team at Charles River Labs is seeking a Quality Assurance Auditor at our site in Newark, DE. 

BASIC SUMMARY:

The QA Auditor will perform final review of basic records, reports, and inspection of sampling processing as well as conduct final release in compliance with applicable regulatory requirements, and corporate policies and procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Review and approve test results.
• Perform QC release of specified reagents and raw materials.
• Report all quality control issues, including but not limited to: OOSs, deviations, observations affecting processes, consumable/ vendor quality, equipment calibration, and training issues to the Quality Manager.
• Collect and organize data for all laboratory investigations.
• Collect and organize laboratory validation data.
• Provide technical support for internal audits.
• Maintain laboratory safety standards and requirements.
• Adhere to all laboratory SOPs.
• Participate in internal facility/SOP procedural audits to obtain a clear understanding of the Quality System and regulatory requirements for the testing operations.
• Recommend and implement improvements for procedures and protocol.
• Adopt work procedures and processes that support company and departmental standards, procedures, and strategic directives.
• Participate in associated GMP training to obtain an understanding of GMP regulations and site SOP requirements.

•    Perform all other related duties as assigned.

• Education: Bachelor's degree (B.A./B.S.) or equivalent in Microbiology or related field.
• Experience: 0 - 3 years laboratory experience.
• Experience with FDA and international Quality System rules and regulations, including planning and implementation, is preferred.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None.
• Other: Must have working knowledge of the Quality System. Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.

•    Must be detail oriented and able to effectively communicate findings verbally and in writing.