Distribution Technician I

Xtant Medical Holdings Inc•Belgrade, MT

About The 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.

Requirements

High School diploma, or equivalent
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.
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.

Nice To Haves

Prior job experience with relative job duties is preferred, but not required
Prior shipping experience with FedEx Ship Manager software preferred

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
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