QA Associate I/II - (FY07-071)

The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Normally receives no instructions on routine work and general oversight and guidance on approaches to complete project related tasks. Applies job related skills and understanding of policies and standards in completing tasks. Evaluation of batch manufacturing records and testing records. Follow-up on preventive and corrective actions associated with deviations, lab investigations and Environmental Excursions. Interact with plant personnel to insure CGMP compliance. Prepare and maintain batch data tables for trend analysis. Provides back up for other QA and plant site personnel as appropriate. The monitoring of compliance with the requirement of GMP.

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Knowledge/Skills Needed:

Working knowledge in FDA Medical Device Quality Systems, and Code of Federal Regulations (21 CFR Part 820, 21 CFR Part 210, 21 CFR Part 211 -Working knowledge of ISO and US and European Drug Product GMP requirements -Strong working knowledge of word processing, spreadsheet and database programs. -Working knowledge of problem solving tools (SPC, Process Mapping, Pareto, cause & effect diagrams, value stream mapping, etc.) - Ability to prioritize and manage multiple projects within aggressive product development schedules. -Training and experience in application of statistics to the test-engineering environment. -Strong verbal and written communication skills. -Ability to interact effectively in a matrix management system to accomplish goals and objectives through cross-functional teams. -Excellent attention to detail and strong organizational skills. -Has a thorough understanding of the regulatory process from GLP through commercial manufacturing. The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Normally receives no instructions on routine work and general oversight and guidance on approaches to complete project related tasks. Applies job related skills and understanding of policies and standards in completing tasks. Evaluation of batch manufacturing records and testing records. Follow-up on preventive and corrective actions associated with deviations, lab investigations and Environmental Excursions. Interact with plant personnel to insure CGMP compliance. Prepare and maintain batch data tables for trend analysis. Provides back up for other QA and plant site personnel as appropriate. The monitoring of compliance with the requirement of GMP.

?

Knowledge/Skills Needed:

Working knowledge in FDA Medical Device Quality Systems, and Code of Federal Regulations (21 CFR Part 820, 21 CFR Part 210, 21 CFR Part 211 -Working knowledge of ISO and US and European Drug Product GMP requirements -Strong working knowledge of word processing, spreadsheet and database programs. -Working knowledge of problem solving tools (SPC, Process Mapping, Pareto, cause & effect diagrams, value stream mapping, etc.) - Ability to prioritize and manage multiple projects within aggressive product development schedules. -Training and experience in application of statistics to the test-engineering environment. -Strong verbal and written communication skills. -Ability to interact effectively in a matrix management system to accomplish goals and objectives through cross-functional teams. -Excellent attention to detail and strong organizational skills. -Has a thorough understanding of the regulatory process from GLP through commercial manufacturing.