Packaging & Labeling Technician I in Belgrade, Montana at Xtant Medical Holdings Inc

Classification: Full Time, Non-exempt

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

Financial Responsibilities

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; 8:00 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

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.