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.
