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Eurofins · 1 month ago

Quality Assurance Auditor

South Brunswick Township, NJ, USA

Full-time

Onsite

New Grad, Entry Level

$22.50/hr - $25.50/hr

Eurofins is an international life sciences company providing analytical testing services across multiple industries. The Quality Assurance Auditor will assist in various QA functions, conduct inspections, audit data, and ensure compliance with regulatory standards.

BiotechnologyGeneticsHealth CareLife SciencePharmaceutical

Responsibilities

Assist in performance of all Quality Assurance functions as outlined in the GLPs and PSL SOPs. Assist the Quality Assurance Director as needed during inspections by EPA, FDA or clients. Prepare records and assemble copies of documents requested by inspectors when advance notice is given and Sponsor and/or Laboratory Director approval is obtained

Conduct in-process study inspections and general facility inspections in the toxicology and chemistry laboratories as directed

Audit raw data and proofread report and tables against raw data for accuracy and for typing corrections. Audit final report to verify corrections

Amend and update Standard Operating Procedures as required using word processing system. File all QAU-related paperwork as directed

Select intervals for inspection for any regulatory test under the auditor's responsibility or as directed by QA Director, Laboratory Director, or President. Perform such inspections in accordance with the test schedule. When the time for conduct of intervals requiring inspection falls outside of normal working hours, this will be brought to the attention of the Study Director or QA Director in order that a suitable arrangement may be made

Ability to safely wear a respirator required

Other duties as assigned

Qualification

FDA/EPA GLP standardsAcute toxicologyAnalytical chemistryCGMPGCPComputer system validationElectronic data captureAALAS certificationMS WordMS ExcelAttention to detailCommunication skills

Required

QA auditors will have experience in a laboratory regulated by FDA/EPA GLP standards

The individual holding this position must be of the highest integrity and have a very strong sense of responsibility

Attention to detail is essential

He/she must be well organized, tactful, be able to work independently and maintain all records, documents, and schedules associated with quality assurance procedures and studies

Communication skills, especially written, are necessary

Proficiency with MSWord and Excel is required

He/she must have a current tetanus vaccination if required to access the vivarium