Quality Control Laboratory Technician

Performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. Conducts and validates various biological and chemical quality control (QC) assays.

ESSENTIAL FUNCTIONS, included but not limited to:

Compiles, interprets, and documents statistical data from testing processes to either confirm compliance with established quality standards or identify deviations.

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.

Maintain retain areas including room temperature storage room and walk-in refrigerator.

Participate in the assigning of values to controls and calibrators.

Maintain control ranges and logs of quality control batches.

Review and keep monthly maintenance logs for all necessary laboratory equipment.

Inspects and releases finished goods.

Perform stability testing and maintain stability records.

Assist in product and equipment validation.

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.

• Associate or bachelor's degree in a science related field.
• Legally authorized to work in the United States.
• One (1) year laboratory experience in a biology, chemistry, or medical environment.
• Pipetting experience.
• Able to understand the basic reasoning and process of the scientific method.
• General knowledge of biological and chemical concepts.

PREFERRED QUALIFICATIONS:

• Working knowledge of chemistry analyzers.
• Two (2) years laboratory experience in a biology, chemistry, or medical environment.
• Experience in a cGMP or regulated environment.
• A Medical Laboratory Technician (MLT) Certification 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.
• Ability to work independently and as a member of various teams and committees.
• Initiative to offer new innovative ideas and improve processes.
• Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
• 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 nonstrenuous 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.