Through collaboration with QC, Manufacturing, Technical Operation, Validations, Facilities, and other operational departments the QA Compliance Specialist will support continuous improvement and companywide efforts to maintain acceptable levels of compliance with internal procedures, corporate requirements and applicable regulations (i.e. FDA, EMA, etc.). This position will support the maintenance of quality systems for exceptions management, approved supplier program, and key performance indicator/metrics monitoring program.
BS degree in a scientific discipline and at least three (3) years of experience working in Quality Assurance with good understanding of GMPs. Pharmaceutical/biotechnology industry experience strongly preferred. T
he ideal candidate is detail minded, organized, and a pro-active thinker with problem-solving skills and the ability to monitor, compile, graph, and verify data.
Must be able to work with cross-functional teams/departments and drive timelines.
Must possess good written and oral communication skills as well as time management skills.
Proficiency in Microsoft Word and Excel required.