Xtant Medical Holdings Inc Hiring for Medical Chart Review – Donor Services Job at Belgrade, MT Full Time

Status: Full Time – Non-Exempt

Reports To: Donor Services Supervisor

A. Purpose and Scope of Position

This position is responsible for ensuring unprocessed human tissue received at Xtant Medical is received, initially cultured, stored, and tracked until it is approved for transplant, non-clinical use, or disposal.

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 his or her department. This position interacts closely with the CLIA Lab personnel and processing personnel and may interact with other departments and employees as required.

B. Organizational Relationship

This position reports to the Donor Services Supervisor. This position may provide additional support to supervisors or other departments as requested.

C. Duties and Responsibilities

• 
  Specific Job Duties/Responsibilities
  • Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA); American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; Medical Device Single Audit Program (MDSAP); and other regulatory jurisdictions, as applicable, to help the company lead the Medical Device and Biologics industries in quality practice
  • Adhere to Xtant Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards
  • Develop and maintain an understanding of the Xtant products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
  • Perform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures
  • Represent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with recovery partners, customers, and fellow employees
  • Receive, inspect, and store unprocessed quarantined tissue when it arrives at Xtant Medical. This may include arranging delivery with a courier after hours, on weekends and holidays
  • Receive and inspect procurement blood/serum/plasma samples and cultures from unprocessed donors. Samples will be forwarded to the Biologics Diagnostics Lab for testing or shipped to outside agencies
  • Perform and document required cleaning of surfaces before and after donor 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 scheduled 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 used to store 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
  • Ensure that donor information is shared with Recovery Agencies in a timely manner
• 
  Financial Responsibilities
  • Submit timely expense reports and abide by the Expense Reimbursement Policy
• 
  Training
  • 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
• 
  Management
  • This position does not supervise others
  • Work with and support the activities of the Donor Services Department and support other divisions as requested
• 
  Document Control and Record Control
  • 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.
  • Write and revise a variety of technical documents including SOPs
  • Maintain information in physical and electronic files as required
• Other duties as assigned
  
• Performance of Duties
  • 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, Recovery Agencies, surgeons, and end users
  • Maintain a clean and safe working environment at all times
  • Must maintain confidentiality of donor and recipient information according to HIPAA

D. Job Requirements

• 
  Education/Credentials Experience & Training
  • Associate’s 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
• 
  Technical Requirements/Skills
  • 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

3. Managerial Experience

• N/A

4. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications

• Must be able to reason independently and work with minimal guidance
• Ability to interpret data and make sound judgments based on those interpretations
• Must deal effectively with a wide variety of personalities and situations requiring tact, judgment, 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 judgment in recognizing scope and authority
• Must possess mobility to work in a standard office setting and to use standard office equipment and to attend meetings at various sites within and away from the office

5. Working Conditions

• Working conditions include a normal office environment, laboratory setting, environmentally controlled area (ECA), clean rooms, and other sterile environments
• May require on-call schedules
• Work may require long periods of sitting and working at a computer
• Work may require occasional weekend/evening/holiday work and 4+ hours of standing
• Duties will include contact with human tissue, blood, bone, and fluids

6. Health and Safety

• Must adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products
• This position will sometimes be required to wear personal protective equipment (PPE), including but not limited to a laboratory coat, scrubs, and gloves, etc.
• Requires OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
• 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
• Must be able to lift 60 lbs.

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.

This position does not offer current or future H-1B Visa Sponsorship

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.