Bio-Manufacturing Technician II - Processing

Xtant Medical Holdings Inc•Belgrade, MT

About The Position

This position will perform 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 Processing Team Lead(s) and Supervisors. This position interacts with employees in the Processing Department and may interact with other department supervisors, team leads, and personnel as necessary.

Requirements

High school diploma required
Minimum of one (1) year experience in biologics production and/or aseptic tissue processing is required
Must have basic knowledge of FDA, ISO, and AATB regulations, as applicable
Must have 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, meaningful conclusions
Ability to identify safety risks and manage appropriately
Must be able to 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
Experience with records maintenance and document control is required
Must complete assigned training and be competent in several aspects (>75%) of tissue processing
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.
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, and decontamination areas and in the handling of company products
This position will often 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 experience or training in the routine handling of chemicals and biohazards
Will require OSHA blood borne pathogen training, SDS familiarity, and other safety training as applicable

Nice To Haves

Two-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 and maintain Certified Tissue Bank Specialist (CTBS) certification
Knowledge of human anatomy preferred
Familiarity with basic laboratory techniques, such as acid-base reactions, measuring and mixing reagents, and general laboratory equipment is desired
Ability to interpret data and make sound, independent judgments based on those interpretations
Demonstrated ability to identify, address, and resolve production-related issues
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
Encourage development of a positive, productive work environment
Mechanical aptitude or an understanding of simple mechanical systems is advantageous
Willing to acquire and maintain Trainer Status, as necessary
Willing to become efficient in Chart Technical Review
Willing to acquire Equipment Qualification Status, as necessary
Strongly encouraged to obtain and maintain CTBS certification

Responsibilities

Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21 Parts 820 and 1271, American Association of Tissue Banks (AATB), International Organization for Standardization (ISO) 13485, European Medical Device Directives (MDD), Canadian Medical Device Regulations, Occupational Safety and Health Administration (OSHA), and other regulatory standards as applicable
Adhere to all Xtant Standard Operating Procedures (SOPs) and safety protocols while operating in compliance with regulatory standards
Develop and maintain an understanding of Xtant products and general biological and chemical systems utilized within the Processing Department. Know how the activities performed in the Processing Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
Support the Xtant mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients
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 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 blood borne 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
Assist with error and nonconformance investigation within the quality system
Accurately enter appropriate donor and graft information into material tracking reports
Assist in donor tissue and material movement
Support stored tissue inventory and record keeping tasks
Must maintain confidentiality of donor and recipient information
Provide recovery agency feedback on tissue quality
Upon hire, employee will rotate through processing support teams in order to learn various tasks associated with production and donor processing.
Provide assistance and support to other teams, departments, team leads, and supervisors as requested
Submit timely expense reports and abide by the Expense Reimbursement Policy
Responsible for participating in training plans and programs and completing assigned training in a timely manner within set deadlines
Complete all required training prior to attempting to perform a task
Maintain accurate and detailed training documentation. Ensure training is up to date
Complete Document Read Training (DRT) within required deadlines whenever a document within the Quality System undergoes revision
Assist in the completion and retention of production-related and processing-related documents and records
Assist in the completion and retention of documentation pertaining to all SOPs as required
Legibly and accurately complete all documentation associated with assigned duties in accordance with current GDP and review the information of others as required
Participate in the completion of Donor Processing Records as applicable
Participate in changes to documents and to products and processes
Maintain information in physical and electronic files as required
Other duties as assigned
Complete required training prior to performing tasks, including initial orientation and environmental health and safety training. 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