Purpose and Scope of Position

This position will perform activities related to production, product design and development, quality, and regulatory compliance in their department as assigned.

This person does not typically supervise others and will support the activities of the department team lead(s) and manager.

This position interacts with employees in the department and may interact with other department supervisors, team leads, and employees.

This position works with the department team lead(s) and manager and with other technicians at the research and development or production and processing level to help ensure that Xtant Medical complies with and meets the standards of the Food and Drug Administration (FDA), American Association of Tissue Banks (AATB), International Organization of Standardization (ISO) 13485, and other regulatory agencies as necessary.

B. Organizational Relationship

This position reports to the Packaging & Labeling team lead or manager. This position may provide additional support to other team leads, supervisors, or 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) code of federal regulations, Title 21, Parts 820 and 1271, American Association of Tissue Banks (AATB), International Organization of Standardization (ISO) 13485, European Medical Directive (MDD) and Canadian Medical Device and Tissue Regulations, as applicable, and adhere to standards and regulationsAdhere to Xtant Medical 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 and regulationsDevelop and maintain an understanding of the Xtant Medical 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 applicableSupport Xtant Medical’s mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patientsRead, Review, and maintain an understanding of the company quality manual and know where it is locatedPerform all duties according to Xtant Medical SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measuresComplete annual SOP review and OSHA safety trainingMaintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant Medical SOPsFollow OSHA Blood Bourne Pathogen Standards, Universal Precautions, AATB Standards, and current Good Manufacturing Practices (cGMP), and current Good Tissue Practices (cGTP) during all phases of packaging and labeling, storage, irradiating supplies, and cleaningClean, maintain, and operate instruments and equipment as neededAssist in the Quality Control (QC) functions of examining and inspecting labels and finished good products to ensure that packaging specifications are met as required by SOPsMaintain a basic knowledge of how to navigate through the Processing paperwork to establish and assign expiration dates for processed tissue and devices according to SOPsIn a team environment, assist in the completion of the department’s sterilization processes for product and raw materialsLearn and maintain the knowledge of Xtant Medical product lines and the product codes that are associated with themUnderstand Microsoft applications (Word, Excel, Access, Outlook, etc.

for minor reporting responsibilities and data entryBe able to use equipment such as Industrial label printers and sealers.

Common office equipment such as copy machines are also usedAssemble finished good products with designated labeling materials and print labels using barcode softwareExecute day-to-day materials coordination to promote manufacturing operations and quality efficiencies and effective control in a Good Manufacturing Practices (GMP) regulatory environmentCoordinate the shipping and receiving of materials for various departments as requestedCoordinate supply usage reports for the ERP systemAssist in maintaining and suggesting ERP software relating to inventory, purchasing, and all materials managementEnsure appropriate inventory levels are maintainedMust be able to work in a fast-paced team environment producing maximum results to meet company goalsMaintain weekly inventory counts showing the average usage of finished goods and raw materialsOperates FedEx and UPS shipment manager software to generate labels and documentsCommunicate with Customer Service and other departments as necessaryPerform quality check on finished goods and complete corresponding customer order paperwork in accordance with SOPPackage and ship customer orders in accordance with SOPAssist in annual inventory audits and reconciliationAny other duties as assigned

• Financial Responsibilities Submit timely expense reports and abide by the Expense Reimbursement Policy
• Training Participate in training plans and programs and complete in a timely manner within set deadlines. See SOP 050-002Complete required training prior to attempting to perform a taskPossess a willingness to train team members as needed on departmental processes
• Management This position does not supervise othersMay sometimes direct the activities of staff to accomplish quality and company objectives as assignedWork with and support the activities of the department team lead(s), manager, and other divisions as requested
• Document Control and Record Control Assist in the completion and retention of documentation pertaining to all SOPs (Standard Operating Procedures) as requiredWrite and revise a variety of technical documents including SOPs, quality standards and specifications, training documents, and inspection and testing protocols as needed and assignedLegibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as requiredParticipate in the completion of Device History Records (DHR) or Donor Processing Records as applicableParticipate in changes to documents and processes as requestedMaintain 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 datePerform 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 customersMaintain a clean and safe working environment at all timesMust maintain confidentiality of donor and recipient informationMust maintain confidentiality of donor and recipient information according to HIPAA

D. Job Requirements

• Education / Credentials Experience & Training High School Diploma or equivalent is required. Two to four years’ college preferredExperience with company SOP’s document control or regulated environment preferredBasic knowledge of anatomy is a plus
• Technical Requirements / Skills Some knowledge of FDA, ISO, and AATB requirements as applicable
• Ability to write, review, and edit technical reports and SOPs
• Knowledge of aseptic techniques
• Ability to communicate effectively both orally and in writing
• Must possess excellent organizational skills and strong attention to detail
• Basic computer skills required such as basic 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 have excellent manual dexterity and good eye / hand / foot coordination
• Must be able to perform repetitive tasks / motions
• Must be able to lift, push, and pull 60 lbs.

5. Working Conditions

• Working conditions include normal office environment, laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
• Work may require occasional weekend / evening work
• Work may require 4 hours of continuous standing
• Will safely operate machinery such as sealers, surgical instrumentation, and other laboratory equipment
• May work in conditions leading to minor personal discomfort such as temperatures above or below personal comfort levels
• Duties may 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 often be required to wear personal protective equipment (PPE), including laboratory coat, hair and shoe covers, and gloves
• Hepatitis B vaccine is highly recommended and provided to employees who may have contact with human tissue at no cost to the employee.

• May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable

Last updated : 2024-05-24