Packaging & Labeling Technician I

Xtant Medical Holdings Inc; Belgrade (MT); In loco; USD 42.000 - 62.000; Tempo pieno

Descrizione del lavoro

Xtant Medical Holdings Inc. in Belgrade, MT, seeks a detail‑oriented technician to support production, product design and regulatory compliance. You will work with the team to ensure FDA, AATB, ISO 13485 standards are met and maintain GDP/GMP practices.

The role involves document control, labeling QC, inventory management and collaboration with multiple departments. Training in safety and environmental health will be provided, with emphasis on accuracy and confidentiality.

Competenze

• High School Diploma or equivalent required; 2–4 years college preferred.
• Experience with SOPs, Document Control, and regulated environments preferred.
• Basic knowledge of anatomy and aseptic techniques preferred.

Mansioni

• Develop and maintain understanding of industry standards and regulations (e.g., 21 CFR 820, 21 CFR 1271, AATB, ISO 13485).
• Contribute to the organization’s mission, values and quality policy.
• Maintain safe, clean work environment and proper waste disposal per OSHA and SOPs.
• Assist in QC by examining labels and finished goods for packaging specs.
• Navigate processing paperwork to set expiration dates and manage tissue/device records.
• Support sterilization processes and product flow within the department.
• Use labeling equipment and ERP for inventory and materials management.
• Coordinate shipping/receiving and generate labels/documents with shipping software.
• Maintain accuracy in documentation per GDP and HIPAA confidentiality.

Conoscenze

Independent work

Data interpretation

Written communication

Attention to detail

Organization

Adaptability

Formazione

High School Diploma or equivalent

2–4 years college preferred

Descrizione del lavoro

Reports to: Packaging & Labeling Team Lead

• 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.

• Supervisory Responsibilities
  • This position does not supervise others or teams
• 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
• Submit timely expense reports and abide by the Expense Reimbursement Policy
• Training
  • Complete required training, including but not limited to initial orientation and environmental health and safety training prior to performing tasks
  • Participate in training programs, ensuring timely completion and accurate, up-to-date training records
  • Complete annual SOP review and safety training (i.e. OSHA, bloodborne pathogens) as applicable
  • May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
  • May require experience or training in the routine handling of chemicals and biohazards
• Document Control and Record Control
  • Complete all documentation accurately and legibly per GDP, retain records according to Xtant Medical’s procedures, and review others’ documentation as needed
• Performance of Duties
  • Perform duties and responsibilities to the highest standards with efficiency, professionalism, and attention to detail; adapt to job changes and contribute to team success
  • Maintain confidentiality of donor and recipient information according to HIPAA
• 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; 8:0 am – 5:0 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

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.