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.

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.