Status: Full Time – Non-exempt

Reports To: Bio-Manufacturing Support Supervisor

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 Bio Manufacturing Support Supervisor. This position interacts with employees in the Tissue Processing Department and may interact with other department supervisors, team leads, and personnel as necessary.

B. Organizational Relationship

This position reports to the Bio-Manufacturing Support 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); American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; Medical Device Single Audit Program (MDSAP); and other regulatory jurisdictions, as applicable, 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
   • 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 with error investigations, and resolution, within the quality system
   • 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
   • Operate, monitor, and maintain autoclaves 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
   • Responsible for decontamination, disinfection, cleaning, and sterilization (where appropriate) of all non-disposable processing instruments and equipment
   • Manually wash processing instruments and equipment according to Xtant SOPs
   • Ensure all reusable tissue processing equipment and instruments are suitable for use, including inspection and assembly if applicable
   • Prepare relevant donor processing documentation, labels, and other consumable supplies for sterilization
   • Aseptically introduce equipment and supplies into the cleanroom environment
   • Safely operate, monitor, and maintain cleaning and sterilization equipment in accordance with manufacturer recommendations and equipment-specific SOPs when applicable
   • Safely prepare and handle cleaning reagents and solutions according to SDS and SOPs and follow OSHA bloodborne pathogen standards, Universal Precautions, and current Good Tissue Practices (cGTP) when handling biological material
   • Provide facility cleaning support to areas outside of the cleanroom environment
   • Collect and prepare soiled cleanroom garments for shipment to vendor
   • Collect and prepare solid biohazardous waste for shipment in accordance with OSHA standards and Xtant SOPs
   • Know the appropriate storage conditions, locations, and tissue handling methods for unprocessed and processed donor tissue
   • Aid and support 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
4. Management
   • This position does not supervise others
5. Document Control and Record Control
   • Assist in the completion and retention of documentation pertaining to all SOPs as required
   • Assist in the completion and retention of production-related and processing-related documents and records
   • Legibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as required
   • Participate in the completion of Donor Processing Records as applicable
   • Participate in changes to documents, 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 is required
• Must be willing to acquire Certified Tissue Bank Specialist (CTBS) certification
• Some familiarity with basic laboratory techniques and equipment, aseptic practices is preferred, but not required
• Experience working in sterile environments, healthcare or medical device production is preferred, but not required
• Experience with records maintenance and document control is preferred, but not required

1. Technical Requirements/Skills
   • Must be willing to acquire knowledge of FDA, ISO, and AATB regulations, as applicable

• Ability to 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

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 areas, and decontamination areas and in the handling of company products
• This position will 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 training in the routine handling of chemicals and biohazards
• Will require OSHA (bloodborne pathogen) training, SDS, 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.

This position does not offer current or future H-1B Visa Sponsorship

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.