Job Location : Saint Just,PR, USA
Bachelor's Degree is required; Sciences; Biology, Biotechnology, Microbiology, Industrial Microbiology or Engineering disciplines is highly preferred OR Associate's degree plus 6 years of directly experience in a quality role within the regulated industry (pharmaceutical, medical device or biotechnology) OR High School degree plus 8 years of directly in a quality role within the regulated industry (pharmaceutical, medical device or biotechnology).
At least five (5) years of directly experience in a manufacturing operation or quality role in Parenteral or Pharmaceutical Industry
Previous experience with three (3) to five (5) years of in a supervisory / managerial position, with at least three (3) years of experience in Parenteral or Pharmaceutical Industry
Two (2) years of experience in GMP Environmental Monitoring or Utilities Sampling activities is preferred. Experience in clean room environmental monitoring and aseptic technique is a preferred.
Proven technical knowledge in Parenteral or Pharmaceutical environmental monitoring program, aseptic operations, isolators, sanitization and sterilization process.
Must have knowledge in compendium requirements (e.g.: FDA, EMEA), cGMP, GLP, and FDA regulations and the ability to interpret and apply them.
Fully bilingual (Spanish/English) communication skills, both written and verbal. Excellent technical writing skills (English/Spanish)
Strong leadership skills, time management and planning.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirn consideracin para el empleo sin importar raza, color, religin, sexo, orientacin sexual, identidad de gnero, informacin gentica, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.