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.