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Job Title: Quality Engineer
Job Location: NJ: Ridgefield
Pay Rate: Open
Job Length: full time
Start Date: 2008-08-27

Company Name: Genzyme
Contact: Human Resources
Phone: email only please
Fax: email only please

Description: Quality Engineer

Requisition ID 13185 Working Location Ridgefield, NJ Required Education See Description Required Travel No

Position Description This individual will be responsible for overseeing the non conformance and corrective and preventive action processes. The position requires the utilization of problem solving tools and techniques, and statistical analyses for NCR and CAPA investigations, and for process improvement initiatives. Strong statistical background, technical writing and decision making skills are necessary for this position. This individual will be responsible for reviewing and approving NCR and CAPA investigations, ensuring the use of appropriate tools prior to MRB approval. In addition the person is responsible for review and accuracy of the weekly, monthly and quarterly reports as they relate to the NCR, CAPA and metrics reporting. This individual may be responsible for presenting the department metrics during the management review meetings. This individual will be the liaison in the implementation of a new global CAPA NCR software package (TrackWise) and to assist in the implementation of other software packages as deemed necessary. Some computer system validation and 21CFR Part 11 compliance and QC test equipment validation experience is a plus. The person must be detail oriented, and able to handle a variety of projects simultaneously while managing the NCR/CAPA processes and material review board meetings. Program management is a plus as this individual will have the opportunity to be a site project manager/leader on special projects when available. This position requires interaction with R & D, Mfg, QC, and other departments as necessary to ensure accuracy and completion from early development through product launch. Modifies, applies and maintains quality standards as they relate to development or modifications of protocols, reports or specification and standard operating procedures for various projects as they relate to project management or computer system validations. Coordinate and maintain project timelines to ensure deliverables and milestones are met. Individual should have a general knowledge of ISO, cGMP and FDA regulations as they relate to both pharmaceuticals and medical devices. Must be a self-motivated, professional achiever with a positive attitude. This person should be able to work easily with others as well as independently, without direct supervision. This is a fast-paced environment. Attention to detail is a critical component. Basic Qualifications Bachelors degree with 2 - 4 years experience. NCR and CAPA processing experience and knowledge of software applications and project management and presentation skills. Preferred Qualifications: Experience facilitating meetings and ability to work with all levels of manufacturing and management may be required.

Please refer to Job code genzyme-63674 when responding to this ad.

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