A. Purpose and Scope of Position
This position will perform support activities related to donor tissue processing while maintaining quality and regulatory compliance within their department. This person does not supervise others and will support the activities of the Circulation Team Lead(s) and Supervisors. This position interacts with employees in the Processing Department and may interact with other department supervisors, team leads, and personnel as necessary.
B. Organizational Relationship
This position reports to the Circulation Team Lead or Supervisor. This position may provide additional support to other team leads, supervisors, or departments as requested.
C. Duties and Responsibilities
1. Specific Job Duties/Responsibilities
• Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB); International Organization of Standardization (ISO); European Medical Device Directives (MDD); and Canadian Medical Device Regulations, as applicable, and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice
• Adhere to Xtant Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards
• Develop and maintain an understanding of the Xtant products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
• Support the Xtant mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients
• Maintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant SOPs
• Responsible for decontamination, cleaning, and environmental monitoring of the cleanroom areas and non-sterile equipment used to process donor tissue
• Responsible for maintaining inventory of processing supplies/reagents and other materials within the cleanroom environment and other areas throughout the processing facility
• Ensure supplies are acceptable for processing use and stock is rotated using the First-In First-Out (FIFO) method. Aseptically transfer supplies into the cleanroom environment to maintain adequate inventory and whenever needed
• Obtain environmental samples for surface, air, and water monitoring in conjunction with laboratory testing protocols
• Assist in the preparation and transportation of soiled processing instruments, equipment, cleanroom garments, and biohazardous waste throughout the processing facility
• Operate, monitor, and maintain lyophilizers (freeze-dryers) in accordance with the manufacturer’s recommendations and equipment-specific SOPs
• Transport unprocessed and processed donor tissue across campus
• Know the appropriate storage conditions, locations, and tissue handling methods for unprocessed and processed donor tissue
• Provide facility cleaning support to areas outside of the cleanroom environment
• Must maintain confidentiality of donor and recipient information
• Provide assistance and support to other teams, departments, team leads, and supervisors as requested
2. Financial Responsibilities
• Submit timely expense reports and abide by the Expense Reimbursement Policy
3. Training
• Participate in training plans and programs and complete in a timely manner within set deadlines
• Complete required training prior to attempting to perform a task
• Complete Document Read Training (DRT) within required deadlines whenever a document within the Quality System undergoes revision
• Upon hire, employee will rotate through other support teams in order to learn various tasks associated with production and donor processing
4. Management
• This position does not supervise others
5. Document Control and Record Control
• Assist in the completion and retention of production-related and processing-related documents and records
• Assist in the completion and retention of documentation pertaining to all SOPs as required
• Legibly and accurately complete all documentation associated with assigned duties in accordance with current GDP and review the information of others as required
• Participate in the completion of Donor Processing Records as applicable
• Participate in changes to documents and to products and processes
• Maintain information in physical and electronic files as required
• Complete document corrections in a timely manner and maintain error rates at or below departmental benchmarks
6. Other duties as assigned
7. Performance of Duties
• Complete required training, including initial orientation and environmental health and safety training, prior to performing tasks. Keep training up to date
• Perform all duties according to established procedures and follow appropriate safety precautions and measures
• Conduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end users
• Maintain a clean and safe working environment at all times
• Must maintain confidentiality of donor and recipient information according to HIPAA
D. Job Requirements
1. Education/Credentials Experience & Training
• High School Diploma or equivalent
• Willing to acquire Certified Tissue Bank Specialist (CTBS) certification
• Some familiarity with basic laboratory techniques and equipment is desired
• Experience in healthcare or medical device production is preferred, but not required
• Familiarity with aseptic practices and/or experience in sterile environments is preferred, but not required
2. Technical Requirements/Skills
• Must be willing to acquire knowledge of FDA, ISO, and AATB regulations, as applicable
• Develop an understanding of aseptic techniques and practices
• Demonstrate capability to communicate effectively both orally and in writing
• Ability to multitask and manage time efficiently
• Must be able to adapt to quickly changing priorities and schedules
• Must possess excellent organizational skills and impeccable attention to detail
• Must be able to reason independently and work with minimal guidance
• Basic computer skills are required, such as knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
• Some experience with records maintenance and document control preferred
3. Managerial Experience
• N/A
4. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications
• Must have excellent manual dexterity and good eye/hand/foot coordination
• Must be able to perform repetitive tasks/motions
• Must be able to record information legibly by hand
• Must be able to lift, push, and pull 60 lbs.
• Ability to interpret data and make sound, independent judgments based on those interpretations.
• Must be able to compose oneself in a professional and courteous manner in all aspects of interaction with fellow employees and use good judgment in recognizing scope and authority. Represent the company in a professional manner to the public, customers, and vendors and maintain trusting, respectful relationships with physician partners, customers, and fellow employees.
5. Working Conditions
• Working conditions include normal office environment, environmentally controlled areas (ECAs), cleanrooms, and decontamination areas
• May require evening work and weekend work
• Shift times may vary depending on the needs of the department. Employee’s shift will be subject to change based on those needs
• May require 4+ hours of continuous standing
• May work in conditions leading to minor personal discomfort such as in temperatures above or below personal comfort levels
6. Health and Safety
• Duties will include direct contact with human tissue, blood, bone, and fluids
• Must adhere to all health and safety requirements specified when entering processing, device manufacturing, and decontamination areas and in the handling of company products
• This position will often be required to wear personal protective equipment (PPE), including but not limited to scrubs, laboratory coat, gloves, face shields, helmets, boot covers, and sterile suits
• Will require experience or training in the routine handling of chemicals and biohazards
• Will require OSHA blood-borne pathogen training, SDS familiarity, and other safety training as applicable
• Hepatitis B vaccine is highly recommended and provided to employees who may have contact with human tissue at no cost to the employee. Any employee who declines a Hepatitis B vaccine will be required to sign a waiver
Note: This Job Description is not designed to include a detailed listing of the activities, duties or responsibilities that may be required of the employee. This job description does not constitute an employment contract, implied or otherwise, and is subject to change by the employer as the needs of the employer and requirements of the job change.
Xtant Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
