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Quality Assurance Auditor, Chemistry
BUSINESS UNIT: Eurofins Product Safety Labs, Dayton, NJ
QUALIFICATION REQUIREMENTS:
JOB SPECIFIC SKILLS:
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.
EDUCATION AND EXPERIENCE:
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.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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