Quality Assurance Auditor

Eurofins•Brunswick Township, MN

1d•$23 - $26•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Experience in other quality standards such as cGMP or GCP will also be considered.
Experience with acute toxicology, analytical chemistry, and/or general laboratory procedures is preferred.
B.S. degree in biology, toxicology, animal science or related field and/or AALAS certification at the Technician level is also preferred.
Experience in computer system validation and electronic data capture is desirable but is not required.

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.
Bring to the attention of the Study Director or QA Director when the time for conduct of intervals requiring inspection falls outside of normal working hours.
Ability to safely wear a respirator required.
Other duties as assigned.