QA Auditor I

BASIC SUMMARY: Provides auditing oversight in support of the company’s quality system and regulated products and services such as the USDA, FDA, VMD, EU, etc. These audits will mainly consist of "paper" audits to support the CRL regulated business units that provide GLP testing services or GMP testing services and production.

PRINCIPAL DUTIES AND RESPONSIBILITIES: The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed, as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

•Collect and assemble data used in the various GLP/GMP test reports. Review each of these reports and prepare QA statement as may be required to release test reports.

•Assist CRL Quality Assurance Management in both the planning and conducting of internal audits.

•Prepare audit reports for review by either the Quality Assurance Supervisor or other QA/RA Directors/Managers.

•Work with the document control group in issuance of GMP batch records and GLP protocols; review batch records to ensure compliance with Standard Operating Procedures and Good Manufacturing Practices.

•Review and release all raw in-process materials and final products against specifications; review and release contract testing samples received for either GLP/GMP testing.

•Review all temperature, humidity, and magnehelic charts/gauges monitoring all environmentally controlled barrier and storage areas.

•Review all autoclave charts to ensure cycle adequacy as compared to internal procedural limits of autoclave processes.

•Prepare reports that provide history and trend analysis as may relate to quality goals. These may include product failures, in-process non-conformance, etc.

•Perform initial review of Quality Control data for validation packages assuring conformance of operating procedures and specifications as well as other regulatory commitments.

•Maintain the GLP Master Schedule.

•Perform all other related duties as assigned.
REQUIREMENTS
NOTE: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The QUALIFICATIONS, PHYSICAL DEMANDS, and WORK CONDITIONS listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities perform the essential functions.

QUALIFICATIONS:
•Associates degree (A.S.) or Bachelor's degree (B. A.) from college or university in Microbiology, Biology or equivalent; and

•One to two years’ quality assurance-quality control related experience and/or training; or

•Equivalent combination of education and experience.

•Knowledgeable in the use of a personal computer.

PHYSICAL DEMANDS:
•While performing the duties of this job, the employee is frequently required to type at a computer or typewriter.

•The employee must regularly lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and depth perception.

WORK ENVIRONMENT:
•While performing the duties of this job, the employee occasionally works with computers.

•The noise level in the work environment is usually quiet.