Laboratory Operations Specialist 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 Laboratory Operations Specialist I for our Manufacturing site in Ave Maria, FL The Lab Ops Specialist maintains and contributes to improving 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.
• Ensure adequate BSL consumable inventory levels and initiate order requests within SAP for consumables and external testing.
• 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.).
• 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.
• 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.
• Ability to learn sample collection and benchtop test methods and assist with sample collection and testing as needed.
• Assist in selection, mentorship and curriculum development for BSL intern program.

Education and Experience:

• Bachelors Degree required, preferably in Science related field.
• Previous experience working in a regulated or manufacturing industry and supporting a Quality Management System is preferred.

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

Knowledge of administrative procedures and systems such as word processing, managing files and records, Excel, PowerPoint, Documentum, Quest, SAP, and Microsoft Applications.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalent if changed by the Company), QAD or similar inventory software.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive 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 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.

The area where this job is performed 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.