Quality Assurance Coordinator

About the role

Bone Bank Allografts, a subsidiary of Globus Medical Inc., specializes in processing and distributing high-quality bone allografts for various medical procedures, including orthopedic, dental, and reconstructive surgeries. Our commitment to excellence, supported by Globus' renowned engineering, drives our mission to advance patient care and medical innovation through precise and efficient allograft processing and distribution.

Position Summary

The Quality Assurance Coordinator will work within the Quality department to assist in compliance activities of the quality system and participate in continuous improvement. The primary function of the QA Coordinator is to work with the Manufacturing, Distribution and IT Departments to review and print labels for finished and work in progress products. The position responsibilities may include the following, although other duties and responsibilities may be assigned as necessary.

Essential Functions

• Review allograft reports to verify the data entry of finished goods coincides with the distribution software
• Complete the printing of all final product labeling (final, barcode, and box labels) and verify accuracy of labels printed
• Complete the printing of all work-in-progress (WIP) labeling for routine manufacturing as well as aseptic lines
• Assist the Distribution department with the completion of re-labeling and/or re-designated products as requested
• Assist in onboarding new private label clients by generating sample labels for DCO implementations
• Work with the BBA supply team to maintain adequate label inventory levels
• Collaborate with IT to test label software system updates and trouble shoot label software and/or hardware malfunctions, as needed
• Manage private label client spreadsheet to ensure accurate client information transfer to label templates
• Organize and file final release paperwork weekly to prepare for release to final goods
• Create Manufacturing charts in preparation of Quality review
• Perform monthly inventory reconciliation of product in Quarantine and QA Hold statuses
• Perform Quality review of assigned records or logs and verify procedure requirements were met for approval and closure of the records
• Support the Quality department as a backup for coordinating CAPA system data entry and communication
• Perform other duties and responsibilities as necessary
• Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Bone Bank Allografts and Globus
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications

• High school diploma or higher
• One year office experience preferred, to include filing, scanning and data entry
• Must be knowledgeable with Microsoft Word and Excel programs
• Strong typing and numeric entry skills
• Strong attention to detail
• Must be a flexible team player capable of working in a deadline driven environment

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 this job.
• The employee is required to sit for long periods of time; occasionally responsibilities require employee to bend and stoop, push/pull and reach above shoulder level.
• The employee must occasionally move and/or carry up to 25 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.