C. R. Bard, Inc.

  • QA Lab Tech

    Posted Date 3 weeks ago(10/30/2018 3:51 PM)
    Job ID
    2018-12521
    Career Level
    experienced
    Relocation
    No
    Location
    PR-HUMACAO
  • Overview

    The QA Laboratory Technician will be responsible for assuring testing to materials, components and finished products in to ensure compliance to standards, specifications in accordance with clearly defined procedures. Participate in any Chemical or Microbiological testing to ensure properly completion. Assure the performance of laboratory testing and ensure efficacy, quality and reliability of QA Laboratory testing such as: microbiological and chemical.

    Summary of Position with General Responsibilities

    The QA Laboratory Technician will be responsible for assuring testing to materials, components and finished products in to ensure compliance to standards, specifications in accordance with clearly defined procedures. Participate in any Chemical or Microbiological testing to ensure properly completion. Assure the performance of laboratory testing and ensure efficacy, quality and reliability of QA Laboratory testing such as: microbiological and chemical.

    Essential Job Functions

    • Review and approve appropriate documentation ensuring compliance to requirements.
    • Initiate and managed laboratory investigations of deviations and/or failures observed on the QA Lab process.
    • Assists to develop test methods in accordance with assigned projects and quality assurance standards of the Company.
    • Assists in the establishment of inspection and test procedures within Good Laboratory Practices, cGMP's and ISO guidelines and other regulations.
    • Sets up, operates and maintains laboratory equipments required to perform planned tests and corrects or reports faulty equipment and test conditions
    • Perform testing to incoming chemicals and assures results are within specifications and that requirements priorities are expedited.
    • Evaluate, document test results and prepare test reports.
    • Provides support during validation activities. Perform environmental and product testing requested per validation protocol requirements.
    • Summarizes test results and analyzed test data with the QA Laboratory Supervisor or designee.
    • Notify to QA Laboratory supervisor or designee about out of parameters results for any test.
      • Instruct and directs less experienced persons who assists in laboratory work and supports by filling in for absent key position when needed as designated by QA Laboratory Supervisor or designee.
      • Performs laboratory testing such as: Environmental Monitoring, LAL (Endotoxin), Gel-Clot, Bioburden, etc.
      • Maintains records and coordinates proper disposition of retention samples.
    • Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System Regulations (e.g.: FDA Part 820 QSR, Part 58 GLP, ISO   Quality Standard).
    • Responsible to assure is trained before executing any task.
    • Follow EHS procedures for require PPE (Personal Protection Equipment) for execution of laboratory testing.
    • Perform other duties assigned by the QA Laboratory Supervisor or designee.

    Basic Qualifications

    • Must be thoroughly knowledgeable in laboratory test procedures through advance study or a combination of experience and college level study
    • Must have the ability to plan laboratory approaches for unusual situations
    • Must have the dexterity and analytical ability to operate and maintain sensitive laboratory instruments
    • Should have normal color perception
    • Must be accurate in mathematical calculations
    • Must be bilingual (English/ Spanish) and must have good communication skills both oral and written
    • Team work oriented
    • Analytical skills
    • Quality and results oriented

    Education and/or Experience

    • BS in Science related (Biology, Microbiology or Chemistry)
    • At least three (3) to five (5) years experience as a Laboratory Technician in Medical Devices or related pharmaceutical industry.

    Physical Demands

    Walking – Intermittent 40%

    Sitting – continuous 60%

    Work Environment

    • Hours of operation are flexible and vary depending on job requirements. Typical work week is 40 hours with additional/variable hours for specific work periods and projects. Specific work days and hours are flexible and may change with advance notice 
    • The nature of the work requires exposure to chemicals, noise. Exposure to machinery and non-ionizing radiation
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