Sr. Laboratory Process Improvement Specialist

Integra LifeSciences-posted 4 months ago
Mid Level
1,001-5,000 employees
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The Senior Laboratory Process Improvement Specialist will partner with Integra’s internal operational laboratories to implement programs to improve their quality, reliability, and throughput. Under direct supervision of Program Director – Laboratory Services, this individual will have a dotted line reporting structure to the local site laboratory leader. The Sr. Lab Specialist will be responsible for implementing continuous improvement programs, identifying and tracking quality and operational key performance indicators, implementing compliance programs, and partnering with other Integra laboratories to execute harmonization projects at their local site. An understanding of laboratory operations/GLP/ISO 17025 is required. The position reports into Global Laboratories, Microbiology and Sterility Assurance (GLMS) but will be located on-site at our Plainsboro, NJ manufacturing facility.

  • Responsible for implementation of global procedures and systems at local on-site laboratories
  • Create and revise procedures for laboratory operations, including harmonization/standardization of existing procedures to global processes
  • Collaborate with cross-functional team to support and optimize ongoing laboratory initiatives
  • Identify, track, and interpret relevant key performance indicators to monitor quality compliance risk and operational excellence within local laboratories
  • Implement laboratory continuous improvement program, including identification of new opportunities, scoping, and execution
  • Identify and facilitate technical talent training, mentorship or development programs for laboratory staff
  • Drive quality culture improvements within the laboratory
  • Bachelor’s degree is required, preferably Master of Science degree, in Engineering, Science or similar discipline
  • Bachelor degree or equivalent with 5+ years of experience, Master degree with 3+ years of experience, Doctoral degree with 0-2 years of experience
  • 4+ years of experience in a laboratory or manufacturing engineering in a medical device or pharmaceutical environment
  • Creative thinking and proactive problem-solving skills
  • Demonstrates excellent organizational and verbal and written communication skills
  • Results oriented with a strong focus on quality principles
  • Excellent technical writing skills with an understanding of good documentation practice
  • Experience with test method validations and managing projects independently
  • Experience implementing continuous improvement programs in a laboratory or manufacturing environment
  • Working knowledge of Good Laboratory Practices (GLP)
  • Ability to track milestones and manage projects
  • Lean Six Sigma training/knowledge preferred
  • Experience with implementing LIMS software preferred
  • Experience with PowerBI, Visio, AgilePLM
  • Working knowledge of applicable standards including, but not limited to: ISO 17025, ISO 13485
  • Ability to travel up to 5-10%
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