CooperVision, a unit of The Cooper Companies, Inc. (NYSE:COO), is one of the world's leading manufacturers of soft contact lenses and related products and services. The Company produces a full array of monthly, two-week and daily disposable contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism and presbyopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com JOB TITLE: Chemist II DEPARTMENT: Quality JOB SUMMARY The incumbent will perform chemical analysis assuring compliance with regulatory agencies and procedures. ESSENTIAL FUNCTIONS Trains personnel when necessary. Executes protocols and engineering studies related to laboratory processes. Performs sampling (water, components, other as required). Performs chemical analysis of components and manufacturing materials, manufacturing solutions, water monitoring and other applicable test as required. Performs chemical analysis disposition. Assures components are release on time. Reviews documentation. Challenges equipment performance verification. Generates and execute validation protocols. Generates, evaluates and investigates NCR's and assure to close in a timely manner. Complies with good laboratory practices, QSR, PAL and ISO 13485 regulations. Complies with safety and environmental regulations. Generates laboratory investigation and assures to close in a timely manner. Performs temperature monitoring, as applicable. Cleans laboratory glassware and equipment used during analysis. Keeps laboratory areas clean and organized. Performs minor troubleshooting and maintenance to laboratory equipment. Notifies laboratory supplies and equipment inventory needs to perform analysis. Supports other areas as required (e.g. special tests for validations) Verifies periodically the expiration date and re-assay due dates of components and manufacturing materials, reagents, standards solutions. Generates DCO's, ECO's and create and revise procedures. Complies and Maintain 6S (ROLESS) in the Laboratory POSITION QUALIFICATIONS KNOWLEDGE, SKILLS AND ABILITIES Able to work overtime if necessary. Work under minimum supervision. Good oral and written communication skills (English/Spanish). Ability to read, write and comprehend instructions in both languages English/Spanish. Knowledge of QSR (Quality System Regulations) and ISO 13485. Good skills of sampling techniques. Good skills of chemical laboratory methods and techniques. Good skills in analytical chemistry concepts (i.e. concentration determinations, chemical formulations, etc.) Good Laboratory Practices (GLP), safety knowledge and reagents management as per MSDS. Good mathematics skills (i.e. average, rounding rules, multiply, divide, add, subtract, percentage, linear regression, standard deviation, relative standard deviation etc.). Basic Computer skills (i.e. excel, word, power point) Problem solving and initiative skills. 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 judgement to solve problems. Applies communications skills to perform work and speaks clearly and persuasively in positive or negative situations. Incumbent could be expose to fumes of chemicals. EDUCATION Bachelor's degree in science with major in Chemistry with four (4) years of experience in medical devices or pharmaceutical industry quality assurance laboratory or equivalent experience. EXPERIENCE At least four (4) years of experience in medical devices or pharmaceutical industry and chemical quality laboratory. Experience conducting trending reports and laboratory investigations. Experience in equipment as HPLC, GC, TOC, IR, UV, titrations, pH, conductivity, others. Experience in HPLC and GC troubleshooting '220822 SDL2017
