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Lead Quality Assurance Testing Engineer

2 months ago

Indianapolis, Indiana, United States Harba Solutions Inc. Full time

Primary Responsibilities:

  • Formulate and supervise methodologies for method validation, verification, and transfer, including the creation and endorsement of associated protocols.
  • Provide direction and assistance to Quality Control Analysts in crafting and executing method validation, verification, and transfer processes.
  • Engage with suppliers to investigate and assess analytical methodologies and equipment for product and analyte characterization.
  • Gather and evaluate supplier data regarding expenses, installation, calibration, and upkeep of new apparatus utilized in method validation, verification, or transfer. Compose Standard Operating Procedures for new devices or software as necessary.
  • Guarantee compliance with both domestic and international regulatory standards and guidelines (e.g., FDA, EP, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).
  • Draft and oversee Change Controls, Protocols, Corrective and Preventive Actions, and Periodic Reviews, ensuring conformity with departmental training and qualification standards.
  • Manage the safe handling of radioactive substances, ensuring that team members adhere to ALARA principles and achieve quarterly ALARA targets.
  • Offer expert advice on the scientific components of methods, analytical testing, evaluation, and interpretation of laboratory findings, along with other Quality Control-related issues as required.
  • Generate Change Controls within Quality Management systems.
  • Support laboratory personnel with instrument maintenance, troubleshooting, qualification, validation, and training.

Required Qualifications:

  • A Bachelor's Degree in Chemistry or a related field is essential.
  • A minimum of eight years of pertinent experience is necessary.
  • In-depth knowledge of laboratory instrumentation and methodologies such as HPLC, GC, IC, ICP-MS, FTIR, UV, and wet chemistry techniques.
  • Experience with Lean methodologies, Operational Excellence, or 5S is advantageous.
  • Familiarity with Root Cause Analysis tools (e.g., Fishbone Diagram, 5 Whys, Is/Is Not Analysis) is a plus.