Packaging & Labeling Technician I

Job Summary

This position will perform activities related to production, product design and development, quality, and regulatory compliance in their department as assigned. 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), Association for Advancing Tissue and Biologics (AATB), International Organization of Standardization (ISO) 13485, and other regulatory agencies as necessary.

Duties and Responsibilities

• Develop and maintain an understanding of relevant industry standards and regulations including but not limited to 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485, ensuring compliance with these requirements across the organization.
• Actively contribute to the fulfillment of Xtant Medical’s mission, values and quality policy
• Maintain a safe, clean work environment and ensure proper disposal of hazardous and non-hazardous waste according to OSHA guidelines and Xtant Medical standard operating procedures (SOP)
• Develop and maintain an understanding of Xtant Medical products
• Understand the interaction of departmental activities with the Quality System and their impact on the production of medical devices and human cells, tissues, and cellular and tissue-based products (HCT/Ps)
• Adhere to Xtant Medical SOPs, Good Documentation Practices (GDP), and safety protocols
• Follow OSHA Blood Bourne Pathogen Standards, Universal Precautions, AATB Standards, current Good Manufacturing Practices (cGMP), and current Good Tissue Practices (cGTP)
• 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 department’s 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
• Be able to use equipment such as Industrial label printers and sealers, and common office equipment
• Assembles finished good products with designated labeling materials and print labels using barcode software
• Coordinate the shipping and receiving of materials as needed
• Assist in maintaining appropriate inventory levels and materials management within ERP software
• Operate FedEx and UPS shipment manager software to generate labels and documents
• Communicate with Customer Service and other departments as needed
• Other duties as assigned

Required Skills/Abilities

• 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 in a fast-paced environment
• Ability to communicate effectively both orally and in writing
• Must possess excellent organizational skills and strong attention to detail

Education & Experience

• High School Diploma or equivalent is required.
• Two (2) to four (4) years’ college preferred
• Experience with Standard Operation Procedures (SOP), Document Control, and/or regulated environment is preferred
• Basic knowledge of anatomy and aseptic techniques is preferred

Working Conditions

• This position is based in an office/laboratory/warehouse environment
• Standard work hours are Monday – Friday; 8:00 am – 5:00 pm, with occasional overtime or weekend work based on project/production needs
• This position is based on site in Belgrade, MT
• Working conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments with varying temperatures
• Duties may include contact with human tissue, blood, bone, and fluids
• 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 be required to wear personal protective equipment (PPE), including laboratory coat, scrubs, and gloves, etc.
• 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

Physical Requirements

• Ability to sit, stand, and work at a computer for prolonged periods
• Ability to lift, carry, push or pull items of varying weight, typically up to 60 lbs.
• Ability to move, bend, or twist the body in various ways
• Ability to perform repetitive motions, such as reaching, grasping, bending, squatting, and stooping
• Requires hand-eye coordination and manual dexterity for tasks such as typing, using hand tools or equipment, and assembling or handling small components with precision
• Ability to see clearly, whether with or without corrective lenses
• Ability to hear and understand safety signals, alarms, and customer requests in a noisy environment