Xtant Medical

Packaging & Labeling Technician I

Title: Packaging & Labeling Technician I
Status: Full-Time, Non-Exempt
Packaging & Labeling Team Manager
Location: Belgrade, MT

Summary:

Why Xtant Medical?

JOIN A RISING organization that is focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal fixation systems. Xtant Medical’s mission is to provide cost-effective technology and services that help clinicians efficiently perform their job.

Position Summary

Xtant Medical is seeking a talented and dedicated Packaging & Labeling Technician I that will support the company mission to market regenerative medicine products and medical devices.  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.

Principle 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 regulations.
  • 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 and regulations.
  • Develop 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 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.
  • Complete annual SOP review and OSHA safety training.
  • Maintain 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 SOPs.
  • Follow 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 cleaning.
  • Clean, maintain, and operate instruments and equipment as needed.
  • Assist 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 SOPs.
  • Maintain a basic knowledge of how to navigate through the Processing paperwork to establish and assign expiration dates for processed tissue and devices according to SOPs.
  • In a team environment, assist in the completion of the departments sterilization processes for product and raw materials.
  • Learn and maintain the knowledge of Xtant Medical product lines and the product codes that are associated with them.
  • Understand Microsoft applications (Word, Excel, Access, Outlook, etc.) for minor reporting responsibilities and data entry.
  • Be able to use equipment such as Industrial label printers and sealers. Common office equipment such as copy machines are also used.
  • Assemble finished good products with designated labeling materials and print labels using barcode software.
  • Must be able to work in a fast-paced team environment producing maximum results to meet company goals.
  • Maintain weekly inventory counts showing the average usage of finished goods and raw materials.
  • Operates FedEx shipment manager software to generate labels and documents.
  • Communicate with Customer Service and other departments as necessary.
  • Perform quality check on finished goods and complete corresponding customer order paperwork in accordance with SOP.
  • Package and ship customer orders in accordance with SOP.
  • Assist in annual inventory audits and reconciliation.
  • Any other duties as assigned.

Position Requirements

  • 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.

Education/Knowledge/Skills Required

  • High School Diploma or equivalent. Two to four years college preferred.
  • Experience with company SOP’s document control or regulated environment preferred.
  • Basic knowledge of anatomy is a plus.

Benefits: Xtant Medical offers competitive wages, and comprehensive Medical, Vision, Dental, 401k, Life and AD&D, and Disability insurance packages

No H1B Sponsorships Available for this Position

Xtant Medical is an equal opportunity employer.  We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors.