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 Specialist works within the Quality Department to assist in compliance activities of the quality system and participate in continuous improvement activities. The primary function of the QA Specialist is to provide review and release of product records to ensure compliance to company procedure and applicable federal, state, local, and accreditation standards. The position responsibilities may include the following, although other duties and responsibilities may be assigned as necessary:
Essential Functions:
Performs data entry review and release ensuring entry of finished goods coincides with the Distribution software
Performs secondary review of Donor Processing Records for terminally sterilized and aseptic lines
Coordinates with the QA Systems Team Lead or Management to prioritize product release
Performs release functions to finished goods
Reviews test reports as part of release criteria, technical and performance specifications, and irradiation shipment documents for acceptability
Verifies domestic or international requirements for product release
Investigates and tracks status of records pending release
Assists in onboarding new private label clients by verifying label requirements prior to use
Assists Distribution department with the review and release of re-designated products as requested
Performs Quality reviews of assigned records or logs and verifies procedure requirements are met for approval and closure of records
Maintains error spreadsheets and creates graphs/trending reports as needed
Assists with performing the monthly inventory of QA product
Reports non-conformances and discrepancies
Participates in continuous improvement initiatives and implementations as directed
Performs other duties and responsibilities as assigned
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensures 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
Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:
Bachelor’s degree preferred
Experience performing file reviews and/or audits preferred
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 required
Excellent communication and writing skills required
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; bend and stoop, push/pull and reach above shoulder level. The employee must occasionally move and/or carry up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Our Values:
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate about our role in improving the lives of patients by continuously developing better solutions.
Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.
Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
Driven: We pursue our mission with energy and passion. We are nimble, results-oriented, and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity:
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin, or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.
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.