Assistant Research Scientist I - QA Auditor
The Quality Assurance (QA) Auditor is responsible for conducting the required U.S. Environmental Protection Agency (EPA) (Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)) Good Laboratory Practice Standards (GLP) QA activities for GLP studies performed by SynTech Research Laboratory Services (SRLS), Stilwell, KS.
NATURE OF THE POSITION:
The Assistant Research Scientist 1 – QA Auditor reports to the Manager of Quality Assurance and is responsible for reporting laboratory and field findings to appropriate personnel. He/she will also review final field notebooks and study final reports for compliance with Good Laboratory Practice regulations and study protocols. He/she interacts on a daily basis with a wide variety of personnel ranging from peers to study directors, supervisors, managers, and directors. He/she participates in setting the internal standard for compliance with the Good Laboratory Practice regulations and monitors the adherence to this standard.
- Conduct inspections of vendors, contract field facilities, and SynTech Research field critical phases. May require up to 25% travel, with some international travel.
- Inspect/monitor each GLP study to ensure the integrity of the study and determine that no deviations from approved protocols or SOPs were made without proper authorization and documentation. Written inspection reports must be routed to the Study Director, Study Director Management, and Principal Investigator (PI)/ PI Management when applicable. This practice should follow the GLPs, study protocol, and QAU SOPs.
- Review all protocols for GLP studies in which SRLS acts as study director. A written protocol review inspection report will be submitted to the Study Director and Study Director Management.
- Review the final study reports and PI reports to assure that the such report accurately describes the methods and SOPs and the reported results accurately reflect the raw data of the study for studies/work conducted by the Study Director, and/or principle investigator (PI).
- Prepare a signed QA Statement to be included in each final report and/or PI report.
- Maintain a copy of all study protocols, including amendments and deviations, for all studies in which SRLS acts as study director or principal investigator.
- Index and maintain QA records. The QA records should include a file for each GLP study which includes but is not limited to: a copy of study protocol, amendments, and deviations. All audit reports (protocol, in-life, and final report/PI reports), study notification forms (if applicable), and external quality assurance audits (if applicable). These QA records should be maintained in a locked cabinet. After the completion of the study, the QA study file should be archived.
- Participate in the review of GLP departmental SOPs.
- Annually update CV/Training Records.
- Contact/discuss immediately with Managers/Directors questions or compliance concerns occur.
This position requires a B.S degree in Agriculture or related field with 1-2 years relevant work experience preferably in field research and development. The incumbent must have a working knowledge of common farm practices. Strong communication and organizational skills are a must, as well as the ability to effectively interact with the study directors and study personnel.
On a daily basis, he/she is responsible for assisting in resolving Good Laboratory Practice related problems with study personnel at all levels. This takes initiative, flexibility and a clear analytical ability in order to help resolve issues to the satisfaction of both SRLS personnel and regulatory requirements. The consequences of a study not conforming to the Good Laboratory Practice regulations could elicit minor fines or, more importantly, could result in the rejection of a study which, in turn, could delay the registration of a product for a client.
The Assistant Research Scientist 1 – QA Auditor is responsible for monitoring studies/reports for conformance with Good Laboratory Practice regulations and for alerting the Study Director, Management or Director when questions or compliance concerns occur.