QA Lab Technician II

Johnson & Johnson Innovative MedicineSan Lorenzo, PR
1dOnsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for QA Lab Technician II. Purpose: Under the direction of the Quality Supervisor, Laboratory, or designee, and with the objective of maintaining high Quality Laboratory Practice and compliance with regulatory requirements, performs chemical and physical analysis of raw materials, in process and finished products. Collect environmental samples according to established procedures.

Requirements

  • Bachelor's degree in Science or technical field is required.
  • At least two (2) years of professional experience is required.
  • At least one (1) year of experience in micro/chem laboratory is preferred.
  • Basic Knowledge of computers is required.
  • Knowledge of QSR's and ISO Standards is required.
  • Bilingual proficiency is required (English & Spanish).
  • Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required.

Responsibilities

  • Performed and evaluate required laboratory test on raw materials, in-process, and finished goods materials as per applicable procedures. Also, perform environmental monitoring (example: viable for surface and air) as applicable.
  • Ensure correct and complete documentation of all tests performed, laboratory logbook, and calibrations verifications. Complete all record retention documentation.
  • Confirm the proper inventory of laboratory supplies, environmental monitoring materials, and reagents are available to perform laboratory test / monitoring activities.
  • Document and evaluate results of product endotoxin, bioburden, and sterility test.
  • Keep records following GDP and GMP.
  • Maintain work areas and equipment clean and audit ready according to applicable procedures.
  • Reports any Out of Specification (OOS) condition, escalate, and document / completed the investigation according to established procedures and assuring its completion following the laboratory investigation report timeframe.
  • Coordinates on time calibration of QA laboratory equipment.
  • Collect waste, segregate where required and store in designated areas as per applicable procedures.
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