Distribution Technician I

Status: Full Time Non-Exempt Reports To: Distribution Team Lead A. Purpose and Scope of Position This position will oversee the activities related to picking, packaging, and shipping finished goods product orders to customers to maintain Xtant Medical’s Quality and Compliance policies, as assigned. Responsibilities include but are not limited to receiving, inspecting and maintaining proper storage conditions to ensure safe practices are used during all phases of storage and distribution. This person does not supervise others and will support the activities of the distribution manager, distribution supervisor, and distribution team lead(s). This position works with the distribution manager, distribution supervisor, distribution team lead(s), purchasing, planning and distribution colleagues to process and fulfill customer orders and assess backorders to 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 Distribution Team Lead. This position may provide additional support to other departments as requested. C. Duties and Responsibilities 1. 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 Device Directives (MDD); and Canadian Medical Device Regulations as applicable and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice • Adhere 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 • Develop and maintain an understanding of Xtant Medical products, fulfillment, and distribution systems utilized within the department including product descriptions and SKU’s. 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 • Support Xtant Medical’s mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients • Read, review, and maintain an understanding of the company quality manual and know where it is located • Perform all duties according to Xtant Medical SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures • Maintain required information in appropriate databases including allocating inventory to customers upon order processing • Operates FedEx shipment manager software to generate labels and documents • Track Material with Limited Shelf Life or Expiration Dates to appropriately discard inventory if within expiration window • Employee shift schedules may vary depending on the needs of the department and high peak order times • Receive and store processed tissue when it is released to finished goods. Ensure finished goods are stored by product code, donor number, and expiration date • Use the First In First Out (FIFO) method when selecting inventory • Ensure all processed tissue deemed unacceptable is quarantined in such a manner that distinguishes it from distributable inventory • Receive, inspect, and store shipping supplies according to all SOPs. Ensure the shipping supply storage is maintained in an orderly fashion at all times • Maintain Excel spreadsheet of frozen grafts physical locations • Navigate FedEx Shipping Manager • Pull, process, and package customer orders • Communicate with Customer Service and other departments as necessary • Receive Tissue/Device releases into finished goods • Review and inspect tissue and complete corresponding paperwork for final release into distributable inventory • Assist in quarterly inventory audits and reconciliation • Any other duties as assigned 2. Financial Responsibilities • Submit timely expense reports and abide by the Expense Reimbursement Policy 3. Training • Participate in training plans and programs and complete in a timely manner within set deadlines • Complete required training prior to attempting to perform a task • Maintain required training documentation 4. Management • This position does not supervise others 5. Document Control and Record Control • May assist in the development and maintenance of Document Control and Record Control systems that meet FDA, AATB, and ISO standards and regulations • 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 current GDP and review the information of others as required • Maintain information in physical and electronic files as required • Participate in the Annual SOP review • Train on and demonstrate proficiency in Xtant Medical’s document control system Other duties as assigned 7. 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, surgeons, staff, 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 1. Education/Credentials Experience & Training • High School diploma, or equivalent • Prior job experience with relative job duties is preferred, but not required 2. Technical Requirements/Skills • Some knowledge of FDA, ISO, and AATB requirements as applicable • Ability to multitask • Ability to stay calm under pressure and to work quickly, as needed • Proficient computer skills required such as advanced knowledge of Microsoft Office and other software as necessary • Ability to investigate and analyze information and to draw conclusions • Prior shipping experience with FedEx Ship Manager software preferred • Effective communication skills, oral and written • Attention to detail • Strong organizational and time management skills 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 are normal for an office environment. Standard office hours are Monday – Friday; 8:00am – 5:00pm. Work will require occasional weekend/evening work and occasional travel • May work in conditions leading to minor personal discomfort such as temperatures above or below personal comfort levels • 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 laboratory coat, scrubs, and gloves • Will require experience or training in the routine handling of chemicals and biohazards • May require 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, push, and pull 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, leaves of absence, compensation and training.