Job Description
Job Overview:
Classification: Full Time – Non-Exempt
Reports to: Donor Services Manager
A. Job Summary
This position is responsible for ensuring unprocessed human tissue received at Xtant Medical is received, cultured, stored, and tracked until it is approved for transplant, non-clinical use, or disposal.
This position reports to the Donor Services Manager. This position may provide additional support to supervisors or other departments as requested.
The work week for this position is Monday through Friday, 8:00am to 5:00pm with rotational on-call responsibilities. On-call responsibilities are shared with other team members and will require time outside of scheduled work hours, weekends, and holidays. This person does not supervise others and will support the activities of the department. This position interacts closely with Xtant Medical’s Medical Directors, CLIA Lab, and processing personnel and may interact with other departments and employees as required.
- This position does not supervise others
- 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 (SOPs)
- 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
- Receive, inspect, and store unprocessed quarantined tissue when it arrives at Xtant Medical. This may include arranging pickup or delivery with a courier after hours, on weekends and on holidays
- Transfer tissue throughout the Xtant Medical campus as needed and perform required documentation of the transfer
- Ship unprocessed tissue to partners when necessary and update the Donor Database and Donor Chart as applicable
- Receive, inspect, and store procurement blood/serum/plasma samples and cultures from unprocessed donors. Samples will be stored, archived, and forwarded to the Xtant Medical CLIA Lab or shipped to outside agencies for testing as applicable
- Perform and document required weekly cleaning and cleaning of surfaces before and after donor tissue and sample inspection
- Ensure all unprocessed tissue deemed unacceptable is quarantined in such a manner that segregates it from unprocessed tissue whose status is undetermined or is released and available to be sent to processing
- Discard all unprocessed tissue deemed unacceptable in the appropriate biohazard container and complete all required documentation
- Perform aseptic culture sampling of donor tissue when necessary. Inspect all supplies and equipment prior to handling, aseptically set up a work area, equipment, and supplies for use, and follow aseptic technique during all phases of tissue culturing
- Ensure all low-temperature freezers and refrigerators used to store archive blood samples and unprocessed tissue have been approved for use and have the appropriate signage posted to indicate freezer status
- Receive and compile donor information into the final Donor Chart and complete the Donor Eligibility Assessment
- Communicate with Recovery Agencies and ensure that relevant donor information and records are shared with the applicable Recovery Agency in a timely manner
- Other duties as assigned
- Submit timely expense reports and abide by the Expense Reimbursement Policy
- Participate in training plans and programs and complete them in a timely manner within set deadlines
- Complete required training prior to attempting to perform a task
- Maintain required training documentation
- 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 GDP and review the written documentation of others as required
- Train and demonstrate proficiency in Xtant Medical’s document control system
- Maintain information in physical and electronic files as required
- Perform duties and responsibilities to the highest standards with efficiency, professionalism, and attention to detail; adapt to job changes and contribute to team success
- Maintain confidentiality of donor and recipient information according to HIPAA
- Must be able to reason independently and work with minimal guidance
- Ability to interpret data and make sound judgements based on those interpretations
- Must deal effectively with a wide variety of personalities and situations requiring tact, judgement, and poise
- Must be able to adapt to quickly changing priorities and schedules
- Ability to maintain good working relationships with all co-workers and the general public and use good judgement in recognizing scope and authority
- Associate or bachelor’s Degree, preferably in science, from an accredited college or university is required or equivalent experience
- One (1) year of experience that is directly related to the duties and responsibilities specified
- Must be willing to acquire Certified Tissue Bank Specialist (CTBS) certification
- Prior knowledge and experience in biologics manufacturing or other relevant cleanroom/aseptic environments preferred but not required
- Some knowledge of FDA, ISO, and AATB requirements as applicable
- Ability to write, review, and edit technical reports and SOPs
- Ability to communicate effectively both orally and in writing
- Ability to multitask
- Must possess excellent organizational skills and strong attention to detail
- Proficient computer skills required such as advanced knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
- Ability to investigate and analyze information and to draw conclusions
- Some experience with records maintenance and document control preferred
- This position is based in an office environment
- Standard work hours are Monday – Friday; 8:00 am – 5:00 pm. This position includes rotating on-call responsibilities, which will involve overtime, holiday, and weekend work
- This position is located on-site in Belgrade, MT
- Working conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments with varying temperatures
- This position will sometimes be required to wear personal protective equipment (PPE), including a laboratory coat, hair and shoe covers, gloves, etc.
- Duties may include contact with human tissue, blood, bone, and fluids. Appropriate PPE is required in controlled areas and processes, which may include face shields, eye protection, masks, and any additional PPE as specified.
- Adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products
- 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
- 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.
- 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 customer 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.
