Bone Bank Allografts is the distributor of the SteriGraft® line of high-quality bone and soft tissue allografts to medical professionals. BBA became a part of Globus Medical in 2014 and has continued to help doctors and their patients with over 1 million successful transplantations. Join us!
The Quality Assurance CAPA Coordinator will work with all BBA departments to assist in compliance activities of the quality system and participate in continuous improvement activities. The primary function of the QA CAPA Coordinator will be to issue non-conformances (NCR), corrective and preventative actions (CAPA), Supplier Corrective Action Requests (SCAR), deviations, complaints and rework approvals. The QA CAPA Coordinator will also ensure all NCRs/CAPAs/Complaints have complete information and evaluations, proper investigations, risk analysis, and effective corrective actions implemented.
The responsibilities of the position include, but are not limited to, the following:
- Coordinating all non-conformance issuance and final review
- Maintaining the complaint process and ensuring the complaints are promptly and thoroughly evaluated, closed, and corrective action is taken
- Coordinating the CAPA process and ensure all non-conformances and corrective/preventative action reports; Completing and reviewing Root Cause Analysis for errors
- Organizing the internal auditing schedule
- Coordinating the Donor release receipt for processing
- Maintaining accurate non-conformance/CAPA/SCAR/complaint/Deviation data base and preparing reports, metrics, trends, and graphs
- Participating in continuous improvement functions and implementing changes
- Reviewing processing records, test results, certs, etc.
- Adhering 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
- Representing 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
In order to be qualified for this role, you must possess the following:
- 3+ years’ experience with complaint and CAPA processes, investigations, and documentation; Bachelor’s degree preferred
- QA or QC experience within the biotech/tissue banking industry
- Knowledge of GMP regulations
- Must be knowledgeable with Microsoft Word, PowerPoint and Excel
- Strong typing skills, analytical skills, and problem-solving techniques
- Ability to maintain a service-oriented approach toward internal and external customers
- Excellent communication and writing skills
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.
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 occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.