Biological Safety Lab Scientist Sr I

Requisition ID: 66379 Title: Biological Safety Lab Scientist Sr I

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.

Essential Duties and 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.

Education/ Experience:

• 5 Years of relevant experience with BS Degree in Chemistry, Biology, or related science field required.
• Prior work in a regulated industry preferred.

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

• 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

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 accommodation may be made to enable individuals with disabilities to perform the 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.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually low to moderate.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.