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) StandardsDevelop 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 applicablePerform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measuresRepresent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with recovery partners, customers, and fellow employeesReceive, 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 holidaysReceive 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 agenciesPerform and document required cleaning of surfaces before and after donor sample inspectionEnsure 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 processingDiscard all unprocessed tissue deemed unacceptable in the appropriate biohazard container and complete all required documentationPerform 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 culturingEnsure all low-temperature freezers used to store unprocessed tissue have been approved for use and have the appropriate signage posted to indicate freezer statusReceive and compile donor information into the final Donor Chart and complete the Donor Eligibility AssessmentEnsure that donor information is shared with Recovery Agencies in a timely mannerFinancial ResponsibilitiesSubmit timely expense reports and abide by the Expense Reimbursement Policy
TrainingParticipate in training plans and programs and complete them in a timely manner within set deadlines
Complete required training prior to attempting to perform a taskManagementThis position does not supervise others
Work with and support the activities of the Donor Services Department and support other divisions as requestedDocument Control and Record ControlAssist 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 SOPsMaintain information in physical and electronic files as requiredOther duties as assignedPerformance of DutiesComplete 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 measuresConduct himself / herself in a professional and courteous manner in all aspects of interaction with fellow employees, Recovery Agencies, surgeons, and end usersMaintain a clean and safe working environment at all timesMust maintain confidentiality of donor and recipient information according to HIPAAD. Job Requirements
Education / Credentials Experience & TrainingAssociate’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 specifiedMust be willing to acquire Certified Tissue Bank Specialist (CTBS) certificationPrior knowledge and experience in biologics manufacturing or other relevant cleanroom / aseptic environments preferred but not requiredTechnical Requirements / SkillsSome knowledge of FDA, ISO, and AATB requirements as applicable
Ability to write, review, and edit technical reports and SOPsAbility to communicate effectively both orally and in writingAbility to multitaskMust possess excellent organizational skills and strong attention to detailProficient computer skills required such as advanced knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessaryAbility to investigate and analyze information and to draw conclusionsSome experience with records maintenance and document control preferredManagerial ExperienceN / ASpecial Requirements / Physical Capabilities or Abilities, other Additional Desirable QualificationsMust be able to reason independently and work with minimal guidanceAbility to interpret data and make sound judgments based on those interpretationsMust deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poiseMust be able to adapt to quickly changing priorities and schedulesAbility to maintain good working relationships with all co-workers and the general public and use good judgment in recognizing scope and authorityMust 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 officeWorking ConditionsWorking conditions include a normal office environment, laboratory setting, environmentally controlled area (ECA), clean rooms, and other sterile environmentsMay require on-call schedulesWork may require long periods of sitting and working at a computerWork may require occasional weekend / evening / holiday work and 4 hours of standingDuties will include contact with human tissue, blood, bone, and fluidsHealth and SafetyMust adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company productsThis 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 applicableHepatitis 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 waiverMust 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.
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, lea
ves of absence, compensation and training.
Compensation details : 48000-48000 Yearly Salary
PIce6180317898-25406-35973455
