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!

POSITION SUMMARY:

The Quality Assurance Specialist will work within the Quality Assurance Department to assist in compliance activities of the quality system and participate in continuous improvement activities. The primary function of the QA Specialist will be to provide review of device/product records to ensure compliance to applicable federal, state, local, and accreditation standards. The QA Specialist will audit the Device/Donor Master Records, Design History Files, and Dev ice/Donor History Records for compliance and release criteria.

THE RESPONSIBILITIES OF THE POSITION INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING:

• Performing Device History Record / Donor Processing Record review and release functions
• Auditing design records and files
• Working with MFG to coordinate priority list for release
• Reviewing certificates of compliance and/or test reports
• Reviewing technical and performance specifications
• Providing status updates for records pending release
• Reviewing and approving shipments for IRR and certs
• Reviewing of completed logs
• Creating graphs and trending reports
• Reporting non-conformances and discrepancies
• Creating formal audit reports
• Participating in continuous improvement functions and implement changes for improved
• 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:

• High School Diploma; Bachelor's degree preferred
• Experience performing file reviews and/or audits
• QA or QC experience within the biotech/tissue banking industry preferred
• Knowledge of GMP regulations preferred
• Must be knowledgeable with Microsoft word and Excel programs
• Strong typing skills, analytical skills, and problem solving techniques
• Excellent communication and writing skills

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.

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 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. _