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JOB TITLE: QA -FORMULATION LABORATORY TECHNICIAN II * *DEPARTMENT: Quality JOB SUMMARY The incumbent will be in charge for the preparation of the formulation used for the manufacture of contact lenses. /Also is accountable for the use of Laboratory Instruments operative systems and equipment. Responsibilities are to be performed in compliancewith good laboratory practices, QSR, PAL, ISO 13485 regulations and; safety and environmental regulations/ • Prepares the monomer formulation as per applicable procedures. • Supports all manufacturing lines providing the monomer formulation as required. • Prepares pronto files. • Performs equipment verification. • Performs temperature monitoring. • Complies with good laboratory practices, QSR and ISO 13485. • Complies with safety and environmental regulations. • Participates in laboratory investigations. • Cleans laboratory glassware and equipment use during the mixing process. • Responsible to organize raw materials and segregate products in the freezer accordingly. • Reports usage of raw materials in BPCS. • Performs inventory of the monomer formulation in production area. • Performs periodically inventory of components. • Reviews of documentation. • Notifies laboratory supplies and equipment inventory needs to perform analysis. • Performs simple analysis of monomer mixture (i.e. water content, absorbance, color, viscosity). • Trains personnel when necessary. • Coordinate the disposal of any unused materials, contaminated materials, or out of specification product. • Performs and reports work in a safe and organized manner • Stay current on all job related or function related information and/or training. • Performs chemical analysis, monomer mix formulation. • Challenges equipment performance verification. • Generates NCRs. • Notifies laboratories supplies and equipment inventory needs to perform analysis. • Complies and Maintain 6S (ROLESS) in the HEMA & Proclear Laboratories. POSITION QUALIFICATION /KNOWLEDGE, SKILLS AND ABILITIES/ • * Able to work with minimum supervision. * Dynamic and self-starter. * Able to work overtime if necessary. * Able to read and understand simple instruction in languages, English and Spanish. * Applies communication skills to work as a team group * Needs to apply analytical skills. * Complies with the Quality System Regulation (QSR) and ISO 13485. * Executes job responsibilities as established in the Standard Operating Procedures (SOP). * Knowledge and compliance with Good Laboratory Practices (GLP) and safety knowledge and reagents management as per SDS. * knowledge and skills in analytical equipment * knowledge in chemistry instruments and troubleshooting (Viscometer, Karl Fischer, Colorimeter, etc.) * Good technical writing skills * Leadership skills * Teamwork oriented * Initiative and problem-solving skills * Able to work overtime if necessary, with minimum supervision * Computer skills (i.e. Excel, Word, PowerPoint, etc.) * Good interpersonal skills at all levels * Highly motivated, self-starter, and responsible person /WORK ENVIRONMENT/ * The noise level in the work environment is usually moderate * Needs to walk, stand, use hands to finger, handle, or feel; sit and reach with arms; lift and/or move up to 50 pounds; requires close vision * Utilizes reading, writing, speaking skills, analytical capacity and judgment to solve problems * Applies communication skills to perform work and speaks clearly and persuasively in positive or negative situations * Incumbent could be exposed to fumes of chemicals. /EDUCATION/ * Bachelor Degree in Science. Concentration in Chemistry (Strongly Preferred). /EXPERIENCE/ At least three years of experience in Medical Device, Quality Laboratory and laboratory equipment (Viscometer, Karl Fisher, colorimeter, etc.) CooperVision®, Inc. is an EEO/AA Employer M/F/D/V Job: Manufacturing* *Organization: CVI Quality Assurance Manufacturing *Title: *Manufacturing Laboratory Technician II-HEMA Location: Puerto Rico-Juana Diaz Requisition ID: JUA2005