Bio-Manufacturing Support Tech I

1 month ago

Belgrade MT United States Xtant Medical Holdings Inc Full time

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 Bio-Manufacturing Support Technician to join our team on-site in Belgrade, MT. It offers a pay rate of $22 hourly 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, plus more

Responsibilities of the Bio-Manufacturing Support Technician:

  • Decontamination, cleaning, and environmental monitoring of the cleanroom areas and non-sterile equipment used to process donor tissue
  • Maintain inventory of processing supplies/reagents and other materials within the cleanroom environment and other areas throughout the processing facility
  • Ensure supplies are acceptable for processing use and stock is rotated using the First-In First-Out (FIFO) method
  • Aseptically transfer equipment and supplies into the cleanroom environment
  • Obtain environmental samples for surface, air, and water monitoring in conjunction with laboratory testing protocols
  • Assist with preparation and transportation of soiled processing instruments, equipment, cleanroom garments, and biohazardous waste throughout the processing facility
  • Operate, monitor, and maintain cleaning and sterilization equipment, lyophilizers (freeze-dryers), and autoclaves in accordance with the manufacturer's recommendations and equipment-specific SOPs
  • Decontamination, disinfection, cleaning, and sterilization (where appropriate) of all non-disposable processing instruments and equipment
  • Ensure all reusable tissue processing equipment and instruments are suitable for use, including inspection and assembly
  • Prepare relevant donor processing documentation, labels, and other consumable supplies for sterilization
  • Safely prepare and handle cleaning reagents and solutions according to SDS and SOPs and follow OSHA bloodborne pathogen standards, Universal Precautions, and current Good Tissue Practices (cGTP) when handling biological material
  • Collect and prepare soiled cleanroom garments for shipment to vendor
  • Collect and prepare solid biohazardous waste for shipment in accordance with OSHA standards and Xtant SOPs

Requirements for the Bio-Manufacturing Support Technician:

  • High School Diploma or equivalent is required
  • Must be willing to acquire Certified Tissue Bank Specialist (CTBS) certification
  • Some familiarity with basic laboratory techniques and equipment, aseptic practices is preferred, but not required
  • Experience working in sterile environments, healthcare or medical device production is preferred, but not required
  • Experience with records maintenance and document control is preferred, but not required
  • Basic computer skills are required, such as knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
  • Must have excellent manual dexterity and good eye/hand/foot coordination
  • Must be able to perform repetitive tasks/motions
  • Must be able to record information legibly by hand
  • Must be able to lift, push, and pull 60 lbs.

Working Conditions

  • Working conditions include normal office environment, environmentally controlled areas (ECAs), cleanrooms, and decontamination areas
  • May require evening work and weekend work
    • Shift times may vary depending on the needs of the department. Employee's shift will be subject to change based on those needs
  • May require 4+ hours of continuous standing
  • May work in conditions leading to minor personal discomfort such as in temperatures above or below personal comfort levels

Health and Safety

  • Duties will include direct contact with human tissue, blood, bone, and fluids
  • Must adhere to all health and safety requirements specified when entering processing, device manufacturing areas, and decontamination areas and in the handling of company products
  • This position will be required to wear personal protective equipment (PPE), including but not limited to scrubs, laboratory coat, gloves, face shields, helmets, boot covers, and sterile suits
  • Will require training in the routine handling of chemicals and biohazards
  • Will require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable.
  • 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

About Us:

We aim to improve the quality of life for our patients by designing, manufacturing and distributing medical devices and human tissues for transplants that are safe, effective and meet the needs of our customers.

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.

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



Compensation details: 22-22 Hourly Wage



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