Arthrex Manufacturing - Pendleton, SC

posted 4 months ago

Full-time
Onsite - Pendleton, SC
Miscellaneous Manufacturing

About the position

The Sr. Chemist at Arthrex Manufacturing, Inc. is responsible for performing laboratory testing and activities to support monitoring programs and manufacturing activities in the medical device sector. This role requires a strong background in chemistry and relevant experience to ensure compliance with quality standards and regulations, ultimately contributing to the safety and efficacy of orthopedic devices.

Responsibilities

  • Develop and validate Analytical test methods per ISO/USP with specific emphases on Laboratory QMS.
  • Proceduralize analytical tests as necessary to support orthopedic device requirements and production needs.
  • Establish testing and reporting quality standards in compliance with ISO/IEC 13485 and 17025 for Arthrex laboratory testing activities.
  • Track, trend, and provide statistical analysis for testing data related to the monitoring and maintenance of manufacturing operations, and the associated special process outputs.
  • Enforce corporate specifications for monitoring and maintenance of production and environment standards necessary to maintain the safety of Arthrex products.
  • Evaluate and optimize Arthrex current work instructions and specifications to ensure clear and efficient communication of biological safety standards and requirements for internal and supplier-based manufacturing operations.
  • Identify, develop, and deliver training specifically related to requirements for continued maintenance of the biological safety of medical devices and the impact of those requirements on the manufacturing processes.
  • Assist in the development, implementation, and continued maintenance of LIMS.
  • Perform testing to improve efficiencies and optimize workflow.
  • Provide leadership and direction to staff working in areas as designated.
  • Act as a SME to advise the manufacturer on testing requirements to ensure Biological Safety and regulatory compliance.

Requirements

  • BS Degree in Chemistry, Microbiology or related science field required
  • 5+ years of relevant experience required
  • Experience working and operating Laboratory Information Management Systems (LIMS) required
  • Knowledgeable of cGMP, ISO, and USP guidelines for testing of medical devices required
  • Working knowledge of microbial identification & Characterization, Bioburden, LAL, Cytotoxicty techniques preferred
  • Knowledge of method development and validation experience for analytical instrumental technique and microbial technique preferred

Nice-to-haves

  • Experience with analytical chemistry techniques, (i.e. GC, GC-MS, LC-MS, FTIR, etc.) required
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