Job Description
Description
SUMMARY OF POSITION
Responsible for laboratory testing activities and inspecting clinical testing kits and instruments at various stages of the production process. ESSENTIAL FUNCTIONS
, included but not limited to: ? Perform chemistry laboratory testing of products using appropriate testing equipment and procedures for variety of qualities; Includes dimensions, performance, and mechanical or chemical characteristics using a variety of laboratory instrumentation including, but not limited to, pH meter, centrifuge, spectrophotometer, incubator, or automated analyzer. ? Ensure compliance to meet company standards, specifications, and regulatory requirements. ? Maintain documentation and record testing data in accordance with Standard Operation Procedures (SOPs) and Testing Instructions (TIs). ? Review and inspect manufacturing, packaging, and quality control (QC) lab documents for accuracy and completeness. ? Perform laboratory equipment calibration in accordance with specifications. ? Inspect and release chemical and packaging components. ? Communicate quality or compliance concerns with urgency. ? Adhere to current Good Manufacturing Practices (cGMP). ? Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc. OTHER FUNCTIONS
? Ensure compliance with safety regulations and procedures are followed; Maintain clean and safe work area. ? Assist as needed in other areas of the Company where training requirements have been completed. ? Perform other duties as assigned. SUPERVISORY RESPONSIBILITIES
? None. TRAVEL ? None. Requirements REQUIRED QUALIFICATIONS
? High School Diploma or its equivalent. ? Legally authorized to work in the United States. PREFERRED QUALIFICATIONS
? Associate or bachelor's degree in a science related field. ? Laboratory experience in a biology, chemistry, or medical environment. ? General knowledge of biological and chemical concepts. ? Experience in a cGMP environment. ? Medical Laboratory Technician (MLT) or Medical Technologist (MT) certification. BASIC SKILLS AND ABILITIES
? Working knowledge of Microsoft Excel, Word, and Outlook. ? Detail oriented, accurate, efficient, and accountable. ? Proven ability to meet deadlines; work in a fast-paced environment. ? Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude. ? Ability to work independently and as a member of various teams and committees. ? Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm. ? Ability to operate related office equipment, such as computer, calculator, and copier. ? Able to work with small tools and electronic equipment to test and inspect. ? Demonstrated ability to analyze and interpret information. REASONING ABILITIES
? Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. ? Ability to define problems, collect data, establish facts, and draw valid conclusions. ? Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. LANGUAGE SKILLS
? Ability to read and interpret work related documents, procedures, and manuals. ? Ability to communicate effectively; good written and oral communication skills; ability to read, write, speak, and understand the English language. MATHEMATICAL SKILLS
? Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. ? General knowledge of the metric system units (length, area, volume, capacity, mass, and weight) and U.S. equivalents. VISUAL ACUITY
? Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading. PHYSICAL DEMANDS
? Must be able to wear and work in personnel protective equipment (PPE) as required. ? Light physical activity performing non-strenuous daily activities in a laboratory setting. ? Ability to hear, understand, and distinguish speech. ? Constant repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse; Dexterity and coordination are necessary to handle small components. ? Frequently stand for prolonged periods of time. ? Occasionally move about inside the facility to access office machinery, correspond with other departments, attend meetings/training, etc. ? Frequently lift, carry, push, pull or otherwise move objects up to 10 pounds; occasionally carry, push, pull or otherwise move objects up to 25 pounds. ? Occasionally sitting, squatting, stooping, kneeling, or crouching. ? Occasionally reaching for items above and below desk level. ENVIRONMENT CONDITIONS
? Well lit, heated/air-conditioned indoor laboratory setting with adequate ventilation. ? The noise level in the work environment is moderate. ? Frequent exposure to low temperatures in controlled refrigerators and/or freezers. ? Occasional exposure to biohazards, fumes, and other airborne particles.
