Distribution Technician I

Distribution Specialist

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.

This position reports to the Distribution Manager. This position may provide additional support to other departments as requested.

Duties and 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

Submit timely expense reports and abide by the Expense Reimbursement Policy

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

This position does not supervise others

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

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

Job Requirements

High School diploma, or equivalent

Prior job experience with relative job duties is preferred, but not required

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

Effective communication skills, oral and written

Attention to detail

Strong organizational and time management skills

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.

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

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