| Job Description: | This individual is primarily responsible for performing Quality Control testing products at various stages of Production. This includes both routine (SOP) and special assignments, as well as documentation of findings/results for attachment to Device History Records. Additionally, this individual will lend support as necessary to the daily QC Chemistry core functions Stability Studies, Raw Material Testing, Proficiency Testing, and Customer Complaints. ESSENTIAL FUNCTIONS: " Performs and documents QC Sofia Testing of WIP Production Lots and special evaluation assignments. " Support daily QC Chemistry core functions as needed. " Performs and documents 1st article functional Sofia Final Kit QC Testing. " Support new Sofia product development/improvement projects. " General housekeeping and laboratory organization. " Carries out duties in compliance with established business policies. " Works and communicates effectively and professionally with others. " Capable of working and communicating with other departments regarding testing activities. " Operate laboratory equipment safely, as trained and directed, in accordance with established practices. " Train new Quality Control Technicians. INTERACTIONS: Quality Control Chemists/Supervisor Collaborate on the development of weekly work schedules and maintaining timelines in meeting QC, Production, and Corporate goals. This includes both QC Chemistry and Sofia Test Group functions. Manufacturing- Communicates with various levels of personnel throughout activities performed to ensure results are available for disposition according to Production plans. Materials & Warehousing Collaborate to procure daily use materials via Stock Issue. R & D Ensure Quality Systems support for product development and product improvement projects, including validation testing, stability study execution, and documentation. Quality Engineering Collaborate with QE to provide factual information in a timely manner in support of QC process improvement and troubleshooting efforts. WORK ENVIRONMENT: The work environment characteristics are representative of an office, laboratory, and manufacturing environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines. PHYSICAL DEMANDS: Position requires ability to lift up to 20 lbs. on a regular basis. Up to 90% of time at lab bench or desk, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted. AFFIRMATIVE ACTION/EQUAL OPPORTUNITY STATEMENT: Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/ Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Requirements EDUCATION, SKILLS & EXPERIENCE (indicate if required or preferred): Education/Experience " Bachelor's degree in Chemistry, Biology, Life Science or similar discipline or equivalent experience preferred. " 0-2 years' in Quality Control or manufacturing laboratory environment. " Experience in a medical device, high-volume manufacturing environment strongly desired. Knowledge/Skills " Ability to read, interpret and follow detailed procedures, instructions and drawings " Solid understanding of QSRs/ISO " General chemistry and laboratory skills, GLP/GMP experience " Demonstrated team-oriented interaction skills/professional behavior " Strong written and verbal communication skills " Proficient word processing, data entry, and spreadsheet navigation skills " Must know basic quality terms, definitions and concepts " Must understand traceability (product, material, and calibration) Individual must have a working, technical background and a common-sense knowledge base to be able to make daily decisions regarding Production, QC, and chemistry/biology. Work within defined regulations and timelines. Possess the ability to discern product and process integrity to defined standards and methods, with the initiative to take appropriate action. Problem solving developed to the point of identifying processes and standards in need of improvement and suggesting/initiating appropriate action. Performs daily activities with minimum supervision and demonstrates consistent ability to problem solve/resolve issues associated with various aspects/departmental functions with minimal assistance. Operates predominately independently for routine decision-making and seeks involvement of appropriate individuals when warranted. Have a demonstrated ability to prioritize workload. Individual must be able to apply problem solving/decision making skill to personnel interactions and incidents to successfully diffuse potential problems. |
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| Comments for Suppliers: | 2nd Shift Start time, 2:00 pm End time, 10:30 pm |
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