Supports the Quality Assurance Department in functions/projects.
Responsible for improving the efficiency and effectiveness of all engineering related Quality systems.
Lead multiple projects for the execution of areas of Quality Engineering oversight for Facilities, Utilities, Maintenance and Engineering.
Lead and manage Quality Assurance/Engineering projects related to pharmaceutical manufacturing processes; including process validation, equipment qualification, and change control.
Collaborate cross-functionally with all departments to ensure alignment on Quality standards and regulatory compliance.
Educate and advise personnel on Quality Engineering principles and tools, facilitating analysis of Quality systems and GMP data.

Four-year college or university program certificate in Chemical Engineering, Chemistry, Biochemistry, or related scientific field and 15 years’ experience in Pharmaceutical Development and/or Manufacturing Operations.
Ability to read, analyze, and interpret common scientific and technical journals, regulatory, and compliance documents.
Ability to effectively present information to management and colleagues.
Competence in scientific mathematical skills and statistics, including metric analysis, trending, and reporting.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.

Senior QA Engineer

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