Laboratory Technician II

Demonstrate a primary commitment to patient safety and product quality. Understand and comply with all the regulations governing the quality systems (including ISO 17025 for accredited laboratory) and ensure all training is completed as per Laboratory Training Program. Delivery of key Quality and Performance Objectives. Conduct testing according to written procedures - Environmental Control testing (including water/air & surface microbial/air particulate) of controlled areas within the plant, Endotoxin and Bioburden testing (routine/ batch release/ validation) for Microbiology test support; Raw material, in-process and finished product testing for Analytical test support. Collect, compile and analyse data and prepare laboratory reports. Ensures all notebooks/logbooks/Datasheets are completed and reviewed in a timely manner. Records all information and raw data only on designated forms or logbooks and/or via appropriate systems. Assist manufacturing/operations/quality in solving quality-related problems. Ensures NCE’s, laboratory investigations and out of specification results are documented and reported to Laboratory Management. Ensure equipment standards and other materials are approved/released prior to use. Performs cleaning, preventative maintenance, verification of instruments and equipment where required. Perform new equipment qualifications and requalifications as assigned and write related protocols/reports. Support Internal/External Audits. Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager. To build quality into all aspects of work by maintaining compliance to all quality requirements. Perform and assist with additional duties as may be directed by the Supervisor.

Diploma or Bachelor’s Degree in Analytical Chemistry, Chemistry, Pharmaceutical Science, Chemical Engineering, Biotechnology, Materials Science, or other related science disciplines. 2–5 years of relevant laboratory experience in an analytical or quality control laboratory. Experience in a regulated industry preferred (Medical Devices, Pharmaceutical, Biotechnology, or Chemical Manufacturing). Experience with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) is highly desirable. Experience performing routine laboratory testing.

Hands-on experience with analytical instrumentation such as HPLC/GC, FTIR, Dissolution Testing, pH Meter, and Analytical/Micro Balance. Sample preparation and handling techniques. Calibration, verification, and routine maintenance of laboratory equipment. Ability to troubleshoot minor instrument issues. Knowledge of method execution according to validated procedures. Understanding of GMP, GLP, Good Documentation Practices (GDP), and Data Integrity (ALCOA+ Principles). Knowledge of ISO 13485 and FDA 21 CFR Part 820 / Quality Management System requirements is preferred. Knowledge of laboratory safety and chemical handling. Strong attention to detail and adherence to quality requirements. Good communication and teamwork skills.

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