Classification:
Full Time, Non-Exempt
Reports to:
Bio-Manufacturing Support Team Lead
Job SummaryThis position will perform activities related to donor tissue processing while maintaining quality and regulatory compliance within their department. This person reports to and will support the activities of the Bio-Manufacturing Support Team Lead and Supervisors. This position interacts with employees in the Tissue Processing Department and may interact with other department supervisors, team leads, and personnel as necessary.
Supervisory ResponsibilitiesThis position does not supervise others or teamsDuties 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 (SOP)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 protocolsResponsible for decontamination, cleaning, and environmental monitoring of the cleanroom areas and non-sterile equipment used to process donor tissueResponsible for maintaining inventory of processing supplies/reagents and other materials within the cleanroom environment and other areas throughout the processing facilityEnsure supplies are acceptable for processing use and stock is rotated using the First-In First-Out (FIFO) method. Aseptically transfer supplies into the cleanroom environment to maintain adequate inventory and whenever neededObtain environmental samples for surface, air, and water monitoring in conjunction with laboratory testing protocolsAssist with error investigations, and resolution, within the quality systemAssist in the preparation and transportation of soiled processing instruments, equipment, cleanroom garments, and biohazardous waste throughout the processing facilityOperate, monitor, and maintain lyophilizers (freeze-dryers) in accordance with the manufacturer’s recommendations and equipment-specific SOPs Operate, monitor, and maintain autoclaves in accordance with the manufacturer’s recommendations and equipment-specific SOPsTransport unprocessed donor tissue across campusKnow the appropriate storage conditions, locations, and tissue handling methods for unprocessed and processed donor tissueProvide facility cleaning support to areas outside of the cleanroom environmentResponsible for decontamination, disinfection, cleaning, and sterilization (where appropriate) of all non-disposable processing instruments and equipmentManually wash processing instruments and equipment according to Xtant SOPsEnsure all reusable tissue processing equipment and instruments are suitable for use, including inspection and assembly if applicablePrepare relevant donor processing documentation, labels, and other consumable supplies for sterilizationAseptically introduce equipment and supplies into the cleanroom environmentSafely operate, monitor, and maintain cleaning and sterilization equipment in accordance with manufacturer recommendations and equipment-specific SOPs when applicableSafely prepare and handle cleaning reagents and solutions according to SDS and SOPs and follow OSHA bloodborne pathogen standards, Universal Precautions, and current Good Tissue Practices (cGTP) when handling biological materialProvide facility cleaning support to areas outside of the cleanroom environmentCollect and prepare soiled cleanroom garments for shipment to vendorCollect and prepare solid biohazardous waste for shipment in accordance with OSHA standards and Xtant SOPsAid and support other teams, departments, team leads, and supervisors as requestedOther duties as assignedFinancial ResponsibilitiesSubmit timely expense reports and abide by the Expense Reimbursement PolicyTrainingComplete required training, including but not limited to initial orientation and environmental health and safety training prior to performing tasksParticipate in training programs, ensuring timely completion and accurate, up-to-date training recordsComplete annual SOP review and safety training (i.e. OSHA, bloodborne pathogens) as applicableComplete Document Read Training (DRT) within required deadlines whenever a document within the Quality System undergoes revisionMay require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicableMay require experience or training in the routine handling of chemicals and biohazardsDocument Control and Record ControlComplete all documentation accurately and legibly per GDP, retain records according to Xtant Medical’s procedures, and review others’ documentation as neededMaintain information in physical and electronic files as requiredTrain on and demonstrate proficiency in Xtant Medical’s document control systemParticipate in the completion of Donor Processing Records as applicableParticipate in changes to documents and to products and processesComplete document corrections in a timely manner and maintain error rates at or below departmental benchmarksPerformance of DutiesPerform duties and responsibilities to the highest standards with efficiency, professionalism, and attention to detail; adapt to job changes and contribute to team successPerform 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, surgeons, staff, and end usersMaintain confidentiality of donor and recipient information according to HIPAARequired Skills/AbilitiesMust be willing to acquire knowledge of FDA, ISO, and AATB regulations, as applicableDevelop an understanding of aseptic techniques and practicesDemonstrate capability to communicate effectively both orally and in writingAbility to multitask and manage time efficientlyAbility to analyze information to draw relevant conclusionsAdapt to quickly changing priorities and schedulesMust possess excellent organizational skills and strong attention to detailMust be able to reason independently and work with minimal guidanceBasic computer skills are required, such as knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessarySome experience with records maintenance and document control preferredEducation & ExperienceHigh school diploma requiredWilling to acquire Certified Tissue Bank Specialist (CTBS) certificationSome familiarity with basic laboratory techniques and equipment, aseptic practices is preferred, but not requiredExperience working in sterile environments, healthcare or medical device production is preferred, but not requiredWorking Conditions This position is based in an office/cleanroom/warehouse environmentStandard work hours are Monday - Thursday (2 pm - 1 am), with occasional overtime or weekend work based on project/production needsShift times may vary depending on the needs of the department and employee shifts can be subject to change This position is based on-site in Belgrade, MTWorking conditions will include environmentally controlled areas (ECA), cleanrooms, and other sterile environments with varying temperaturesDuties will include contact with human tissue, blood, bone, and fluids. Working in PPE such as cleanroom suites, with face shields and masks as necessaryThis position will require frequent use of personal protective equipment (PPE), including scrubs, gloves, etc. 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 waiverPhysical 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. May require 4+ hours of continuous standing 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 requests in a noisy environmentNote:
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.
Monday - Thursday (2 pm - 1 am) 24 To 24 (USD) Hourly
