Packaging & Labeling Technician I

Xtant Medical Holdings Inc•Belgrade, MT

2h•$0 - $20•Hybrid

About The Position

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.

Requirements

High School Diploma or equivalent is required.
Some knowledge of FDA, ISO, and AATB requirements as applicable
Ability to write, review, and edit technical reports and SOPs
Knowledge of aseptic techniques
Ability to communicate effectively both orally and in writing
Must possess excellent organizational skills and strong attention to detail
Basic computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
Ability to investigate and analyze information and to draw conclusions
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
Ability to maintain good working relationships with all co-workers and the general public 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
Must be able to lift, push, and pull 60 lbs.
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 often be required to wear personal protective equipment (PPE), including laboratory coat, hair and shoe covers, and gloves
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
May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable

Nice To Haves

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

Responsibilities

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 Directive (MDD) and Canadian Medical Device and Tissue Regulations, as applicable, and adhere to standards and regulations
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 and regulations
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
Read, Review, and maintain an understanding of the company quality manual and know where it is located
Perform all duties according to Xtant Medical SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures
Complete annual SOP review and OSHA safety training
Maintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant Medical SOPs
Follow OSHA Blood Bourne Pathogen Standards, Universal Precautions, AATB Standards, and current Good Manufacturing Practices (cGMP), and current Good Tissue Practices (cGTP) during all phases of packaging and labeling, storage, irradiating supplies, and cleaning
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
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
Perform quality check on finished goods and complete corresponding customer order paperwork in accordance with SOP
Package and ship customer orders in accordance with SOP
Assist in annual inventory audits and reconciliation
Submit timely expense reports and abide by the Expense Reimbursement Policy
Participate in training plans and programs and complete in a timely manner within set deadlines. See SOP 050-002
Complete required training prior to attempting to perform a task
Possess a willingness to train team members as needed on departmental processes
May sometimes direct the activities of staff to accomplish quality and company objectives as assigned
Work with and support the activities of the department team lead(s), manager, and other divisions as requested
Assist in the completion and retention of documentation pertaining to all SOPs (Standard Operating Procedures) as required
Write and revise a variety of technical documents including SOPs, quality standards and specifications, training documents, and inspection and testing protocols as needed and assigned
Legibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as required
Participate in the completion of Device History Records (DHR) or Donor Processing Records as applicable
Participate in changes to documents and processes as requested
Maintain information in physical and electronic files as required
Complete required training prior to performing tasks, including initial orientation and environmental health and safety training. Keep training up to date
Perform all duties according to established procedures and follow appropriate safety precautions and measures
Conduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and customers
Maintain a clean and safe working environment at all times
Must maintain confidentiality of donor and recipient information
Must maintain confidentiality of donor and recipient information according to HIPAA
Any other duties as assigned