Provides technical support to the chemistry laboratory personnel. Performs and/ or review/ approve chemistry laboratory tests to avoid delay in the release of the product, assuring a quality and safety work. Responsibilities: • Approves and reviews documents, assures that the Department complies with internal and external regulations and standards. • Performs any work to avoid the delay in the release of the product. • Analyzes purchase raw materials against established procedures assuring compliance with all regulations and specifications. • Review and/or approval of laboratory documentation. • Audits chemical test procedures, retests, additional testing's and SOP's in the laboratory. • Additional task can be assigned as business needs. • Available to work in extended shift and weekend as needed.
Requisitos:
Education: B.S. in Chemist (Master Degree desirable but not required) Puerto Rico Chemist License (preferred). Preferred Qualifications: At least two years of experience in a Pharmaceutical Industry (preferable). Strong knowledge in HPLC, Atomic Absorption, FT-IR, Karl Fisher, UV/VIS, TOC Analyzer, Polarimeter. Strongly oriented to GMP's, GLP's, OSHA, US Pharmacopeia, EP, Good troubleshooting resolution techniques. Strong knowledge in LIMS etc. Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, internal and external audits. Fully bilingual (English and Spanish languages). Ability to communicate, read, write and understand English/Spanish languages. Work Methodology: On-site 9 months 1st contract 2nd and 3er shift will vary