This position has the purpose to ensure compliance to company policies and procedures by reviewing failures, complains, defects and audits finings in order to coordinate corrective actions. To provide Quality and Regulatory expertise to support company’s business objectives and provide guidance to facilitate continuous quality improvements.
Assist the Quality Assurance Manager in the coordination and monitor of the
Lean Manufacturing and Six Sigma Skills with proven abilities of process and continual
Team Management Skills, Project Management and ability to manage multiple projects
concurrently and based on priority.
Must be familiar with CGMPS as defined by CFR 211, 820 or ISO standards such as ISO
15378, 9001 or 13485.
Knowledge of creation and translation of procedures, problem analysis and corrective action
responses, personnel training
Customer Service focus, strong team player, excellent interpersonal skills
Familiarity with the pharmaceutical, printing or packaging industry, required.
Bachelor degree in Science or Engineering
5 years or more of experience
Knowledge in GMP and FDA regulations.
Fluent in Spanish and English; excellent communication skills in both language.
Possess good verbal and written communication and interpersonal skills.
Should be self-motivated, able to work under pressure and long hours.
Excellent organizational skills, PC Literate