Analista de laboratorio

Revised or Issued by/Date: Ana Celia Zapata

Dept. Approval by/Date: Leslie Santiago Clavell

HR-0009-K Rev.1 Page 1 of 4 CONFIDENTIAL Effective Date

Job Description – Laboratory Analyst

Job Title: Laboratory Analyst

Department: Laboratory (Chemistry or Microbiology)

Reports to: Laboratory Supervisor / Team Leaders

Provides supervision to: N/A

Employment Status:  Non-exempt  Exempt  Consultant

Position Details

Position Summary

Responsible to undertake laboratory activities in accordance with approved quality systems providing high

quality technical laboratory services to clients. Follows procedures and quality system to ensure compliance

with regulatory requirements and agencies.

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Duties and Responsibilities

❖ Performs laboratory procedures requiring technical skills and independent judgment in any of the

following areas chemistry, environmental, biology and microbiology.

❖ Provide analytical support activities.

❖ Participates in general laboratory techniques such as receiving of samples, preparation and collection of

samples for examination may be required.

❖ Comply with standard laboratory methods, practices, procedures, policies,, regulations and laboratory

materials and equipment and with all regulatory agencies requirements.

❖ Operates, adjusts and maintains scientific instruments, including but not limited to pH meters,

spectrophotometers, electrophoresis apparatuses, chromatography apparatuses, flame photometers,

fluorescent immunoassay refractometers, particle counters, microprocessors, analytical balances,

autoclaves and compression testing equipment.

❖ Analyzes results for documentation purposes.

❖ Prepare chemical reagents and biological materials medical according to tests on schedule. formulate;

Assumes responsibility for accuracy in the preparation and standardization of solutions.

❖ Performs a variety of chemical, microbiological or biological analyses on raw materials, products, in-

process materials, or stability samples in support of the company’s quality program.

❖ Captures data and documents test results. Completes test records and reviews data.

❖ Calibrates or verifies calibration of instruments or devices prior to use.

❖ Reviews test results to ensure compliance with standards and reports any quality anomalies.

❖ Designs and execute laboratory testing according to standard operating procedures, makes observations

and interprets findings.

❖ Organizes and store all chemicals substances, fluids and compressed gases according to safety

instructions. Records all data and results in specified forms (paper and electronic) with accuracy and

responsibility.

❖ Maintains equipment and assists in ordering laboratory supplies and materials needed for testing.

❖ Ensures that all safety guidelines are followed strictly at all times and maintains a clean and orderly

environment.

❖ Supports laboratory staff by maintaining glassware, logs, and record books; troubleshooting and

resolving problems and helping with special projects. Maintains glassware by picking-up, cleaning,

washing, sterilizing, and distributing.

❖ Keeps laboratory supplies ready by inventorying stock, placing orders and verifying receipt.

Job Description – Laboratory Analyst

HR-0009-K Rev. 1 Page 2 of 4 CONFIDENTIAL

❖ Keeps equipment operating by following operating instructions, troubleshooting breakdowns,

maintaining supplies, performing preventive maintenance and calling for repairs.

❖ Documents information by maintaining daily logs and equipment record books.

❖ Resolves problems by examining and evaluating data and selecting corrective steps.

❖ Completes projects by assisting project team.

❖ Attends and participates in group and project meetings.

❖ Enhances laboratory and organization reputation by accepting ownership for accomplishing new and

different requests and exploring opportunities to add value to job accomplishments.

❖ Used sophisticated laboratory instrumentation and computer systems to collect and record data.

❖ Prepares for and represents the laboratory during FDA, customer, and ISO audits.

❖ Completes preparation of organic samples for analysis, as well as prepares solid and aqueous samples

for analysis on diagnostic instruments.

❖ Utilize internal LIMS computer database for data entry and communication. Interpret and

report data to various agencies through LIS systems.

❖ Handle data entry, reports SOPs, quality control, etc.

❖ Performs maintenance, troubleshooting, repair and improvement of instrumentation.

❖ Support method validations and protocol executions. ❖ Other Duties: Create or revise standard operating procedures, protocols, test methods, validations and

/ or method transfers.

❖ Receive, label and document samples, when needed.

❖ Performs other duties as assigned.

Working Conditions

Normal for chemical, microbiological and environment laboratory surroundings. Could lift, pull and / or

push objects up to a maximum of 20 pounds. Travel time: 0%

While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch;

use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate

with others in the workplace, including the ability to make and promptly respond to audible cues and

warnings. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others).

Exposed to toxic and/or caustic chemicals such as Sodium Hydroxide, Hydrochloric Acid, Methylene

Chloride, Hydrogen Sulfide Solutions, and more. There is a risk of electrical shock if proper machinery

procedures are not followed as well as the dangers of possible burns from chemicals, fires and combustion

reactions as well as explosions. Safe work practices and proper handling are essential to the success of this

position as well as the safety of all staff members of the laboratory.

The noise level in the work environment is usually moderate. Required to use hands and fingers to feel and

reach with hands and arms, stand; walk; sit and talk or hear, climb or balance; stoop, kneel, crouch, or crawl

and taste or smell.

Works in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. Must

wear PPE. Normally works with simultaneous projects and works under pressure, while performing all tasks

in an accurate, complete and compliant manner. A day as a laboratory analyst will be spent performing test

after test, working with the same materials frequently.

Qualifications

Job Description – Laboratory Analyst

HR-0009-K Rev. 1 Page 3 of 4 CONFIDENTIAL

Minimum Education Requirements

Associate / Bachelor’s Degree in science such as Chemistry or Biology, Microbiology, Math and Statistics.

Continuous education required

Attendance to professional seminars for the optimization of the position and the department.

Update job knowledge by participating in educational opportunities and reading technical publications.

Minimum Experience Required

1+ years of experience with laboratory equipment.

At least six (6) months to one (1) year of experience in a laboratory environment. Knowledge and

understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines.

Required Skills and Competencies

Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all

levels, and to prioritize multiple responsibilities, tasks, and projects simultaneously. Good communication

skills and presentation skills, both written and verbal in Spanish and English. Organization skills to perform

assignments with a high degree of attention to detail. Knowledge on how to use the specialized equipment

commonly used for pharmaceutical, medical devices or chemical facilities, for microbiology or chemistry

tests, as applicable. Solid analytical skills. Comfortable handling potentially dangerous substances, such as

flammable liquids and biohazard materials. Good verbal and written communication skills. Fluent in

Spanish and English. Ability to work effectively in a regulated environment. Ability to apply knowledge

and understanding of basic principles of laboratory procedures. Ability to read and understand SOPs,

methods and test procedures in English. Ability to respond to common inquiries by co-workers, auditors

and supervisory personnel. Ability to comprehend and apply principles up to mathematical calculations and

algebra. As needed, ability to work with concepts such as limits, fractions/percent’s, orders of operations,

ratios, and conversions. Ability to apply basic principles of logical or scientific thinking situations

encountered during the course of work in the quality control department. Computer skills in Microsoft

Office (Word, Excel, PowerPoint) and internet navigation. Intermediate math skills with and ability to

calculate percentages and decimals. Flexibility to work different schedules, including weekends and

holidays, as necessary.

Signatures

I confirm that I received a copy of this job description and understand that it is an accurate representation

of the responsibilities of this position.

Employee’s Name Signature Date

Supervisor’s Name Signature Date

LabChemS Representative Signature Date

Job Description – Laboratory Analyst

HR-0009-K Rev. 1 Page 4 of 4 CONFIDENTIAL

The above statements are intended to describe the general nature and level of work being performed by persons

assigned to this position. They are not intended to be an exhaustive list of all associated responsibilities, skills, efforts,

or working conditions. This job description is not an employment contract and LabChemS Corp. reserves the right to

change, amend, add, delete, and otherwise assign any and all duties, responsibilities, and position titles as it deems

necessary to meet the needs of the business. In compliance with the Americans with Disability Act (ADA) of 1990, the

company will make reasonable accommodations with those individuals with a disability as defined by the ADA.