Bio-Manufacturing Technician I - Processing

Classification: Full Time, Non-Exempt

Reports to: Bio-Manufacturing Team Lead - Processing

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 Team Lead - Processing 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 debriding, shaping, sizing, grinding, milling, demineralizing, labeling, and packaging of human tissue intended for transplantation
   • Know the appropriate storage conditions, locations, and tissue handling methods for unprocessed and processed donor tissue
   • Aseptically set up processing cleanroom, equipment, and supplies for use during processing and packaging procedures
   • Inspect all processing reagents, supplies, instruments, and equipment prior to use to ensure acceptability for use in tissue processing
   • Safely operate, monitor, and maintain processing instruments and equipment in accordance with manufacturer recommendations and equipment-specific SOPs when applicable
   • Safely prepare and handle processing 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
   • Accurately assign and verify appropriate product codes and dimension/volume specifications
   • Perform in-process Quality Control (QC) as required by Xtant SOPs and the Quality System
   • Accurately enter appropriate donor and graft information into material tracking reports
   • Assist in donor tissue and material movement
   • Provide assistance and support to 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
   • Upon hire, rotate through processing support teams to learn various tasks associated with production and donor processing
   • 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
   • Two (2) year degree or more in the Physical or Life Sciences, Healthcare, or Engineering is a plus or equivalent advanced training/certifications and experience
   • Willing to acquire Certified Tissue Bank Specialist (CTBS) certification
   • Knowledge of human anatomy preferred
   • Knowledge and experience in biologics manufacturing or other relevant cleanroom/aseptic environments preferred, but not required
9. Working Conditions
   • This position is based in an office/cleanroom/warehouse environment
   • Standard work hours are Monday – Friday; 6:00 am – 3:00 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.

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Monday-Friday, 6 a.m.- 3 p.m.