Job description

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 Biological Safety Lab Scientist I for our Pendleton, SC manufacturing site. Successful candidates must possess a bachelor’s degree in Microbiology, Chemistry, or another science related discipline. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:
Responsible to perform laboratory testing and activities according to procedures to support monitoring programs and manufacturing activities. Act as a Biological Safety representative to consult and perform the necessary analysis for the safe release of product.

Essential Duties and Responsibilities:
Develop and validate microbiological and/or Analytical test methods per ISO/USP with specific emphases on Laboratory QMS.

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/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:
Bachelor’s Degree in Microbiology, Chemistry, or Science Related field of study 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.) desirable

Working Knowledge of method development and validation experience for analytical instrumental technique and microbial technique preferred

Experience in LIMS, testing environments, and Analytical instruments are highly desirable.

Arthrex 2023 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 or protected veteran status.

Nearest Major Market: Greenville

Nearest Secondary Market: South Carolina

colinoncars.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, colinoncars.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, colinoncars.com is the ideal place to find your next job.