CAPA Coordinator

Globus Medical•San Antonio, TX

About The Position

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 CAPA Coordinator will work with all departments to assist with compliance and continuous improvement activities. The primary function will be to issue Non-Conformances (NCR), Corrective and Preventative Actions (CAPA), Supplier Corrective Action Requests (SCAR), Deviations, Complaints and ensure complete investigations, proper evaluations and risk analysis, and effective corrective and preventive actions are implemented. The position responsibilities may include the following, and other duties and responsibilities may be assigned, as necessary:

Requirements

Bachelor’s degree preferred
2+ years of experience within the biotech/tissue banking industry required
3+ years of experience with complaint and CAPA processes, investigations, and documentation preferred
Knowledge of GMP regulations
Must be knowledgeable with Microsoft word, PowerPoint and Excel programs
Maintain a high attention to detail and strong typing and writing skills
Proficient analytical skills and problem-solving techniques
Excellent verbal and written communication
Ability to maintain a service-oriented approach toward internal and external customers

Nice To Haves

Bachelor’s degree preferred
3+ years of experience with complaint and CAPA processes, investigations, and documentation preferred

Responsibilities

Coordinate all Non-conformance, SCAR, and Deviation investigation issuance, final review, and closure
Manage the complaint process to ensure thorough evaluation, closure, proper corrective action, and prompt and effective customer communication
Manage all CAPA investigations to ensure thorough evaluation, proper root cause analysis, and effective corrective and preventative action is taken as necessary
Maintain an accurate CAPA system database
Prepare reports, metrics, trends, and graphs
Schedule monthly department CAPA status meetings
Report department CAPA status updates to management
Assist with change implementation to drive continuous improvement and efficiency across the organization
Review processing records, test results, certificates, etc., as needed
Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
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 Globus
Other duties and responsibilities as necessary
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.