Lab Technician Analyst

 Job Description:

Our company is looking for a detail-oriented and highly skilled Lab Technician Analyst, performing laboratory tests and analyses to ensure the quality and accuracy of materials and products. Proficient in operating and maintaining a wide range of laboratory equipment, analyzing data, and preparing detailed reports. Committed to ensuring high standards of precision and reliability in all laboratory procedures.

Position Duties & Responsibilities:

·       Performs raw material, in-process and/or finished goods tests and reviews.

·       Able to work in an environment with chemicals safely.

·       Inspects, tests and/or evaluates the precision and accuracy of products, and/or testing equipment.

·       Monitors and reviews environmental charts and/or numeric data.

·       Performs chemical and sterility release of product.

·       Performs sterility, environmental, moisture, residual ethylene oxide, and triclosan testing.

·       Carries out difficult calculations and prepares documentation that shows the results for the test performed.

·       Prepares media and performs quality assurance control checks per USP.

·       Investigate and write out of specification reports.

·       Read and interpret results, performs trend analysis as required.

·       Recommends, amends, and analyzes sampling procedures, test methods, standard operating procedures, and/or inspection measures to lean processes or simplify current practices.

·       Performs other duties assigned as by any member of Laboratory Management.

·       Execute simple microbiology analyses in-process sample and finish products (Microbial count, Environmental Monitoring, and sterility test) to comply with current procedures and Pharmacopoeias.

·       Basic knowledge on microbiology principles, theories, practices and methodology.

·       Basic Technical writing techniques knowledge to perform preliminary laboratory investigation.

·       Completes record of inspection results, acceptance, rejection and disposition for entry into logbooks or computer systems (i.e. LIMS).

·       Support process improvement teams for departmental and company continuous improvement activities (Lean, compliance laboratory processes, etc.)

·       Responsible to ensure adequate systematic control of nonconforming product.

·       Recommends and implements revisions, corrections and changes to test equipment, procedures and methods.

·       Experience on proper use and basic troubleshooting on the following laboratory instrumentations: UPLC, HPLC, GC, FTIR, pH, KF, Particle counter, RCS.

·       Participates on special requests for product testing, such as qualification protocols

·       Initiates and coordinates discussions with quality, engineering, and other relevant departments to develop corrective actions for reoccurring problems

·       Conducts training for lower-level technicians and operations.

·       Cross-trains to support other functional areas.

·       Ensures proper safety and environmental procedures and practices are utilized

·       Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).

Education & Experience Requirements:

·       University / Bachelor’s Degree or Equivalent is required with major on science preferred.

·       Good interpersonal relations and communication skills required.

·       Knowledge of Microsoft Office, LIMS, Empower and other computer software recommended.

·       Demonstrated knowledge and expertise in quality processes and regulatory requirements.

·       Experience working in an FDA regulated environment (21 CFR Part 211 and 211, 21 Part 820, ICH Q7 and/or 21 CFR Part 4).

·       Basic Spectroscopy knowledge (theorical and practical) to evaluate and troubleshoot chromatography analysis, document, and review chromatography and/or spectroscopy (GC, UPLC, HPLC, FTIR, etc.) results that could impact the results for the test performed.

·       Basic wet chemistry techniques related to qualitative and quantitative.