The company is seeking to ensure quality assurance functions are performed according to Good Laboratory Practices (GLPs) and Standard Operating Procedures (SOPs), and to assist with regulatory inspections by agencies like the EPA and FDA.
Requirements
- Experience in a laboratory regulated by FDA/EPA GLP standards.
- 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.
- Experience in computer system validation and electronic data capture is desirable but is not required.
- Proficiency with MSWord and Excel is 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.
Other
- Ability to safely wear a respirator required.
- 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.
- He/she must have a current tetanus vaccination if required to access the vivarium.
