Job Description Summary

The QA Laboratory Technician ensures quality assurance by conducting chemical and microbiological tests on materials, components, and finished products. This role involves maintaining compliance with standards and specifications, developing test methods, and performing laboratory testing to support validation activities.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

• 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.
• Follows 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 completing 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.

• Associate degree in Science related like Biology, Microbiology or Chemistry (desire Chemistry)
• Preferably one year of laboratory experience in the medical device or pharmaceutical industry.
• Bilingual (English/Spanish) with strong communication skills.

• Proficient in laboratory test procedures, with the ability to handle sensitive instrument.
• 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
• Team-oriented with analytical and quality-focused mentality.

• Walking - Intermittent 40%
• Sitting - continuous 60%
• 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

• Exposure to chemicals, noise, machinery, and non-ionizing radiation.