Bio-Manufacturing Support Tech I

Xtant Medical Holdings Inc•Belgrade, MT

12d•Onsite

About The Position

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.

Requirements

High school diploma required
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

Nice To Haves

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
Some experience with records maintenance and document control preferred

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
Submit timely expense reports and abide by the Expense Reimbursement Policy
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
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
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