Biological Safety Lab Scientist Sr I

Arthrex•Pendleton, SC

3d•Onsite

About The Position

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. BSL Scientist I for our Pendleton, SC manufacturing location. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

5 Years of relevant experience with BS Degree in Chemistry, Biology, or related science field required.
Experience in LIMS, testing environments, and Analytical instruments are highly desirable.
Working knowledge of microbial identification & Characterization, bioburden, LAL, cytotoxicity techniques, and/or working knowledge of analytical chemistry techniques, (i.e. GC, GC-MS, LC-MS, FTIR, etc.)
Knowledgeable of cGMP, ISO, and USP guidelines for testing medical devices
Knowledge of test method development and validation experience for analytical instrument technique and microbial technique

Nice To Haves

Prior work in a regulated industry preferred.

Responsibilities

Develop and validate microbiological and/or Analytical test methods per ISO/USP requirements with specific emphasis on QMS compliance.
Proceduralize microbial and analytical tests as necessary to support orthopedic device requirements and production needs.
Establish testing and reporting quality standards in compliance with ISO 13485 and 21CFR Part 820 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.