Location: Ave Maria, FL ER Bonus: $2,500.00

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 Laboratory Operations Specialist who will support the Biological Safety Laboratory to maintain and improve quality standards in compliance with testing and reporting standards per 13485, 17025, and all other applicable regulatory compliance requirements. The Laboratory Operations Specialist role may provide focused support for one or more Biological Safety Lab functions, including sample accessioning, data entry, goods receipt and ordering, Document/Records Management, DEV, NCR, SAP-LIMS, Audit Support, or Change Management and ancillary BSL service tasks. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities

• Laboratory maintenance and cleaning.


• Provide contributors to the lab with study information and updates


• Maintain sample receipt and log in to SAP-LIMS database.


• Maintain external testing data entry.


• Supports the maintenance of the Biological Safety Laboratory systems and documentation.


• Support equipment calibrations, equipment, and process validations (IQ, OQ, PQ)


• Supports collecting, maintaining, and interpreting pertinent regulatory information and test data.


• Supports BSL quality training implementation activities for new and current employees.


• Supports the various BSL Quality System processes (Document Management, Change Management, SAP-LIMS, NCR, DEV, etc.).


• Lead completion of Nonconformances (NCRs) in an effective and timely way as assigned: containment, material disposition plans, evaluations, and action plans.


• Support the development, implementation, and continued maintenance and testing plans of SAP-LIMS.


• Supports business/process owners with developing, revising, and reviewing QMS documents for compliance and completeness.


• Lead and/or participate in delivery of projects.


• Support BSL Continuous Improvement projects.


• Evaluate and optimize Arthrex's current work instructions and specifications to ensure clear and efficient communication of biological safety standards and internal and supplier-based manufacturing operations requirements.


• May support the Internal and External Audit program through audit preparation, handling of documentation requests, and backroom and front room support.

Education and Experience:

• Bachelor's Degree BS or BA required.


• Previous experience working in a regulated or manufacturing industry and supporting a Quality Management System is preferred.

Reasoning Ability:

Ability to define problems collects 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 on the above job requirements. 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 represent those that an employee must meet to successfully perform the job's essential functions. Reasonable accommodations 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 to sit, and use hands and fingers to handle, feel, and reach hands and arms. The employee must occasionally lift and move up to 30 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 represent those an employee encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.