Lab Operations Coordinator

Arthrex, Inc Located in: Ave Maria,  Florida
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Arthrex, Inc Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Position in located in the Arthrex facility in Ave Maria, FL. Main Objective: Coordinate biological safety laboratory study activities. Assist in maintaining the Arthrex biological safety laboratory facilities, material inventory, documents and equipment. To follow established procedures and respond to requests from senior laboratory staff with minimal supervision from management. Essential Duties and Responsibilities: Coordinate and/or conduct testing and analysis as necessary to evaluate the quantity and quality of physical and microbiological substances found on/in manufacturing operations and environments as required by international regulations. Utilizing statistical methods, track, trend, and provide statistical analysis for testing data related to the monitoring and maintenance of manufacturing operations, and the associated special process outputs. Ensure corporate specifications for monitoring and maintenance of production and environment standards necessary to maintain the safety of Arthrex products. Support and manage incoming study requests for external and internal testing: Serve as the contributor and/or point of contact via email and phone in regards to appropriate test plan, study timeline, and updates on daily testing, as well as clarification and response for any questions that may arise. Review and provide feedback on laboratory study requests, ensuring compliance with applicable procedures. Initiate and maintain chain of custody/traceability using the LIMS system, and oversee proper disposition of samples. Procure/process/prepare samples for assigned tests in compliance with GLP, GMP and ISO standards. Coordinate resources, ensure appropriate documentation is complete to ensure compliance, and manage testing status to ensure prompt delivery of results. Assist in submitting, collecting and maintaining external test data. Coordinate biological safety laboratory reagent / test materials / office supply inventory, purchase requisitions, order placement and receipt. Coordinate, manage and document vendor/in-house calibration and maintenance events for laboratory instruments and equipment. Monitor environmental and equipment conditions in labguard software. Coordinate laboratory calibration, maintenance and cleaning. Assist with maintenance of biological safety laboratory systems and documentation. Initiate investigation and deviation forms as necessary, and contribute to NCR & CAPAs. Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management. Education and Experience: High School Dipolma or equivalent required. Bachelor’s degree in Life Sciences preferred. 2 years’ related experience preferred. Knowledge and Skill Requirements/Specialized Courses and/or Training: Ability to work in a lab, at a desk, or in a light manufacturing area, including clean room. Knowledge of and ability to implement GLP, GMP and ISO requirements. Demonstrate excellent organizational skills, record keeping skills as well as good documentation practices. Machine, Tools, and/or Equipment Skills: Experience with Microsoft Office is required. Experience with SAP and LIMS is preferred. 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 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 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; use hands and fingers to handle or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 15-30 pounds. Vision Requirements: Visual acuity necessary to do the job safely and effectively. 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 the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually moderate 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.

CRITICAL REQUIREMENTS

COMPANY INFORMATION

Welcome to Arthrex… we are a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 8,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide.

Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately-held company with a family business culture that is committed to delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact.

We invite you to learn more about Arthrex and the positive contributions we are making to medicine and the communities we serve.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Quality,  R&D / Science,  Laboratory
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: