Job Description

Job Title

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. Self-driven, project oriented and troubleshooting are highly preferred.

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