Sr. Chemist

 Requisition ID:                       61112                          Title: BSL Scientist Sr. I Division: Arthrex Manufacturing Inc (US02) Location: Pendleton, SC

 

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Chemist for our Pendleton, SC location. The Sr. Chemist is responsible for performing laboratory testing and activities according to procedures to support monitoring programs and manufacturing activities.  This position requires a Bachelor’s degree in Chemistry or related science field and 5+ years relevant experience. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Essential Duties and 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.

 

Education and Experience:

• 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

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Knowledgeable of cGMP, ISO, and USP guidelines for testing of medical devices required.
• Working knowledge of microbial identification & Characterization, Bioburden, LAL, Cytotoxicty techniques preferred, and/or working knowledge of analytical chemistry techniques, (i.e. GC, GC-MS, LC-MS, FTIR, etc.) required.
• Knowledge of method development and validation experience for analytical instrumental technique and microbia