Requisition ID:
61112
Title:
BSL Scientist Sr. I (Chemistry)
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 microbial technique preferred
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP or similar inventory software.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Mathematical Skills
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.
Vision Requirements:
Visual acuity is necessary to do the job safely and effectively.
Specific vision abilities required by this job include close vision.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Arthrex Benefits
• Medical, Dental and Vi
Location: Pendleton, SC
Posted: Sept. 23, 2024, 8:19 p.m.
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