Bio-Manufacturing Technician I - Processing

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 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.

Requirements

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
High school diploma required
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

Nice To Haves

Some experience with records maintenance and document control preferred
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

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
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
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
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