Packaging & Labeling Technician I presso Xtant Medical

At Xtant Medical, our mission is to honor the gift of donation by allowing our patients to live as full and complete a life as possible. We are seeking a full-time, non-exempt Packaging & Labeling Tech I  to join our team on-site in Belgrade, MT. It offers a pay rate of $20.00 per hour and includes the benefits listed below. If you enjoy working as a team and want to grow your career, you've found the right place at Xtant Medical!

Benefits: 

• Medical - Dental - Vision
• Generous PTO Schedule
• Corporate Gym Discount
• 401(k)
• Well-Being Programs / LifeBalance Discount Program
• Life & AD&D Life Insurance
• Long-Term & Short-Term Disability
• Tax Savings
• And more...

Responsibilities of the Packaging & Labeling Technician I:

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.

This position reports to the Packaging & Labeling team lead or manager. This position may provide additional support to other team leads, supervisors, or departments as requested.

• 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 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
• Perform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures
• Represent the company in a professional manner to the public, customers, and vendors, and maintain trusting relationships with physician partners, customers, and fellow employees
• 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
•  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
•  Execute day-to-day materials coordination to promote manufacturing operations and quality efficiencies and effective control in a Good Manufacturing Practices (GMP) regulatory environment
•  Coordinate the shipping and receiving of materials for various departments as requested
• Coordinate supply usage reports for the ERP system
•  Assist in maintaining and suggesting ERP software relating to inventory, purchasing, and all materials management
•  Ensure appropriate inventory levels are maintained
•  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 and UPS shipment manager software to generate labels and documents
•  Communicate with Customer Service and other departments as necessary

Education/Credentials, Experience & Training

• High School Diploma or General Education Degree Required

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

Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications

• Must be able to reason independently
• 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 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

Working Conditions

• Standard office hours are Monday – Friday; 8:00 am – 5:00 pm. Work will require occasional weekend/evening work
• Working conditions include normal office environment, laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
• Work will require long periods of sitting, standing, and working at a computer
• Duties may include contact with human tissue, blood, bone, and fluids 

Health and Safety

• 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, MSDS/SDS, and other safety training as applicable
• Must be able to lift 60 lbs.

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.

 This position does not offer current or future H-1B Visa Sponsorship.

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.