This position, using in-depth knowledge of relevant guidance/regulatory documents, is responsible for instrument qualifications and applications (LIMS, Chromeleon, etc), participate in product/process investigations as needed, ensuring required quality and safety standards are being met for our products and processes.
Key Responsibilities: • Perform instrument preventive maintenance, performance verification per schedule and per standards/SOPs as needed. • Perform instrument trouble shooting, support investigation per standards/SOPs as needed. • Write or review validation protocols and technical reports. • Review internal documents / external documents, make recommendation as needed. • Collect, calculate, interpret, document and report test results per ALCOA principles. • Write and take ownership for SOPs related to testing programs, laboratory operations and/or equipment operation, for validation projects, activities related to instrument qualification, for instrument lifecycle management include procurement, qualification, in-use, maintenance/calibration, performance review and retirement. • Perform investigative testing to support laboratory investigations; participate in root cause analysis; lead and write laboratory investigations. Investigate laboratory quality issues and recommend sound corrective actions and resolution. • Perform and review equipment calibration and maintenance; serve as instrument advocate. • Identify appropriate lab instrumentation purchases; perform qualification/validation. • Conduct peer review and approval of data collected by coworkers. • Lead laboratory initiatives or programs. • Train analysts on internal procedures and test methods. • Perform statistical analysis. • Utilize change control systems and Inventory management. • Act as an SME for critical processes and testing. • Lead day to day activities acting as a backup to the supervisor as needed. • Support tracking and reporting laboratory performance metrics.
Minimum requirements:
Bachelor's Degree or Equivalent years of directly related experience or high school +16 yrs; Assoc.+10yrs; M.S & PhD.+0 yrs) The ability to fluently read, write, understand and communicate in English 10 Years of Relevant Experience 2 Years of Demonstrated Leadership Chemistry background with experience in analytical instrument is a must. Sefl-driven, project oriented and troubleshooting are highly preferred.