Bio-Manufacturing Support Tech I

Classification: Full Time, Non-Exempt

Reports to: Bio-Manufacturing Support Team Lead

1. Job Summary

This position will perform activities related to donor tissue processing while maintaining quality and regulatory compliance within their department. This person reports to and will support the activities of the Bio-Manufacturing Support Team Lead and Supervisors. This position interacts with employees in the Tissue Processing Department and may interact with other department supervisors, team leads, and personnel as necessary.

1. Supervisory Responsibilities
   • This position does not supervise others or teams
2. Duties and Responsibilities
   • Develop and maintain an understanding of relevant industry standards and regulations including but not limited to 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485, ensuring compliance with these requirements across the organization.
   • Actively contribute to the fulfillment of Xtant Medical’s mission, values and quality policy
   • Maintain a safe, clean work environment and ensure proper disposal of hazardous and non-hazardous waste according to OSHA guidelines and Xtant Medical standard operating procedures (SOP)
   • Develop and maintain an understanding of Xtant Medical products
   • Understand the interaction of departmental activities with the Quality System and their impact on the production of medical devices and human cells, tissues, and cellular and tissue-based products (HCT/Ps)
   • Adhere to Xtant Medical SOPs, Good Documentation Practices (GDP), and safety protocols
   • 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 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
   • Aid and support other teams, departments, team leads, and supervisors as requested
   • Other duties as assigned
3. Financial Responsibilities
   • Submit timely expense reports and abide by the Expense Reimbursement Policy
4. Training
   • Complete required training, including but not limited to initial orientation and environmental health and safety training prior to performing tasks
   • Participate in training programs, ensuring timely completion and accurate, up-to-date training records
   • Complete annual SOP review and safety training (i.e. OSHA, bloodborne pathogens) as applicable
   • Complete Document Read Training (DRT) within required deadlines whenever a document within the Quality System undergoes revision
   • May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
   • May require experience or training in the routine handling of chemicals and biohazards
5. Document Control and Record Control
   • Complete all documentation accurately and legibly per GDP, retain records according to Xtant Medical’s procedures, and review others’ documentation as needed
   • Maintain information in physical and electronic files as required
   • Train on and demonstrate proficiency in Xtant Medical’s document control system
   • Participate in the completion of Donor Processing Records as applicable
   • Participate in changes to documents and to products and processes
   • Complete document corrections in a timely manner and maintain error rates at or below departmental benchmarks
6. Performance of Duties
   • Perform duties and responsibilities to the highest standards with efficiency, professionalism, and attention to detail; adapt to job changes and contribute to team success
   • 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 confidentiality of donor and recipient information according to HIPAA
7. Required Skills/Abilities
   • 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
   • Ability to analyze information to draw relevant conclusions
   • Adapt to quickly changing priorities and schedules
   • Must possess excellent organizational skills and strong 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
8. Education & Experience
   • High school diploma required
   • 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
9. Working Conditions
   • This position is based in an office/cleanroom/warehouse environment
   • Standard work hours are Monday – Friday; 8:00 am – 5:00 pm, with occasional overtime or weekend work based on project/production needs
   • Shift times may vary depending on the needs of the department and employee shifts can be subject to change
   • This position is based on-site in Belgrade, MT
   • Working conditions will include environmentally controlled areas (ECA), cleanrooms, and other sterile environments with varying temperatures
   • Duties will include contact with human tissue, blood, bone, and fluids. Working in PPE such as cleanroom suites, with face shields and masks as necessary
   • This position will require frequent use of personal protective equipment (PPE), including scrubs, gloves, etc.
   • 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
10. Physical Requirements
    • Ability to sit, stand, and work at a computer for prolonged periods
    • Ability to lift, carry, push or pull items of varying weight, typically up to 60 lbs.
    • May require 4+ hours of continuous standing
    • Ability to move, bend, or twist the body in various ways
    • Ability to perform repetitive motions, such as reaching, grasping, bending, squatting, and stooping
    • Requires hand-eye coordination and manual dexterity for tasks such as typing, using hand tools or equipment, and assembling or handling small components with precision
    • Ability to see clearly, whether with or without corrective lenses
    • Ability to hear and understand safety signals, alarms, and requests in a noisy environment

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.