Quality Assurance Auditor, Chemistry

Title

Quality Assurance Auditor, Chemistry (Dayton, NJ)

Duties Included

The candidate must have experience in a GLP environment, with knowledge of chemical purity determinations, FIFRA chemistry studies and/or GLP bioanalytical assays. Duties encompass assurance of compliance with study protocols, written SOPs and GLP standards; verification of empirical results; and audit of final reports. The auditor must further effectively communicate findings in writing, and work with study personnel to ensure appropriate corrective action is taken.

In addition, the auditor will participate in training activities, monitor the facility for compliance with management approved procedures, assist in sponsor and/or regulatory inspections, and provide QA support for computer systems validation.

Requirements

Bachelor’s degree in chemistry or life sciences and minimum two years direct GLP QA related experience is desired. Experience with various types of chemical analysis, GC, HPLC, GC/MS, LC/MS, IC, titration, etc. is required. CRO experience is an asset. Comprehensive knowledge of protocol, SOP and documentation requirements in a regulated industry is a must.

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, able to work independently, and able to maintain all records, documents and schedules for the QA Unit. Communications skills, especially written, are essential.

Contact Information

Send resume to Mr. Gary Wnorowski Product Safety Labs, 2394 Highway 130, Suite E, Dayton, NJ, 08810 or e-mail at: Gary Wnorowski or fax at: 732-355-3275