Classification: Full Time – Non-Exempt

Reports to: Donor Services Manager

A. Job Summary

B. Supervisory ResponsibilitiesThis position does not supervise othersC.Duties and ResponsibilitiesDevelop 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 policyMaintain 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 protocolsReceive, 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 holidaysTransfer tissue throughout the Xtant Medical campus as needed and perform required documentation of the transferShip 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

D. Financial ResponsibilitiesSubmit timely expense reports and abide by the Expense Reimbursement PolicyE. TrainingParticipate in training plans and programs and complete them in a timely manner within set deadlinesComplete required training prior to attempting to perform a taskMaintain required training documentationF. Document 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 requiredTrain and demonstrate proficiency in Xtant Medical’s document control systemMaintain information in physical and electronic files as requiredG. Performance of DutiesPerform duties and responsibilities to the highest standards with efficiency, professionalism, and attention to detail; adapt to job changes and contribute to team successMaintain confidentiality of donor and recipient information according to HIPAAH. Required Skills/AbilitiesMust be able to reason independently and work with minimal guidanceAbility to interpret data and make sound judgements based on those interpretationsMust deal effectively with a wide variety of personalities and situations requiring tact, judgement, 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 judgement in recognizing scope and authorityI. Education & ExperienceAssociate or bachelor’s Degree, preferably in science, from an accredited college or university is required or equivalent experienceOne (1) year of experience that is directly related to the duties and responsibilities specifiedMust 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 requiredSome knowledge of FDA, ISO, and AATB requirements as applicableAbility 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 preferredJ. Working Conditions This position is based in an office environmentStandard 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 workThis position is located on-site in Belgrade, MTWorking 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

K. Physical RequirementsAbility to sit, stand, and work at a computer for prolonged periodsAbility 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 waysAbility to perform repetitive motions, such as reaching, grasping, bending, squatting, and stoopingRequires hand-eye coordination and manual dexterity for tasks such as typing, using hand tools or equipment, and assembling or handling small components with precisionAbility to see clearly, whether with or without corrective lensesAbility to hear and understand safety signals, alarms, and customer requests in a noisy environment