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Packaging & Labeling Associate

Company: Xtant Medical Holdings Inc
Location: Belgrade
Posted on: August 7, 2022

Job Description:

Status: Full Time - Non-Exempt
Reports To: Bio Operations Manager
A. Purpose and Scope of Position
This position is primarily responsible for executing the day-to-day coordination of materials, the supply chain process, centralized inventory control system, and the shipping and receiving of materials for various departments. This position assists with purchasing company-wide, maintaining inventory levels, maintaining accurate records of all activities and transactions, and schedule inventory counts. When required, this position will perform activities related to production, product design and development, quality, and regulatory compliance in their department as assigned. This position works closely with the Materials Planner and the Supply Chain Manager. This position may provide support to multiple departments.
B. Organizational Relationship
This position reports to the Bio Operations Manager and is responsible for communicating effectively with other individuals within the Materials and Purchasing Departments. This position may provide support to other departments as needed.
C. Duties and Responsibilities
Specific Job Duties/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 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 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 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'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
Read, Review, and maintain an understanding of the company quality manual and know where it is located
Represent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employees
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 supporting ERP software relating to inventory, purchasing, and all materials management
Ensure appropriate inventory levels are maintained
Understand Microsoft applications (Word, Excel, Access, Outlook, etc.) for minor reporting responsibilities and data entry
Clean, maintain and operate instruments and equipment as needed
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
Must be able to work in a fast-paced team environment producing maximum results to meet company goals
Operates FedEx shipment manager software to generate labels and documents

Maintain accurate records of all transactions and activities
Maintain a variety of purchasing & inventory records and reports
Coordinate and organize scheduled inventory counts for assigned areas
Ensure accurate and complete records are kept regarding material use, cost, stock levels, reorder points and other data
Coordinate disposal of biohazardous waste
Maintain dry ice inventory
Receive and inspect shipments and handle all receiving paperwork

Financial Responsibilities Submit timely expense reports and abide by the Expense Reimbursement Policy

Training Participate in training plans and programs and complete in a timely manner within set deadlines
Complete required training prior to attempting to perform a task
Maintain required training documentation

Management This position does not supervise others
Works with and supports the activities of all departments as needed

Document Control and Record Control Assist in the completion and retention of documentation pertaining to all SOPs as required
Legibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as required
Write and revise a variety of technical documents including SOPs (Standard Operating Procedures), quality standards and specifications, training documents, and inspection and testing protocols as needed and assigned
Maintain information in physical and electronic files as required
Train on and demonstrate proficiency in Xtant Medical's document control system

Other duties as assigned

Performance of Duties Complete required training, including initial orientation and environmental health and safety training, prior to performing tasks. 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 end-users
Maintain a clean and safe working environment at all times
Must maintain the confidentiality of donor and recipient information according to HIPAA

D. Job Requirements
Education/Credentials Experience & Training High school diploma or equivalent
One (1) year prior experience with warehouse processes is preferred

Technical Requirements/Skills Some knowledge of FDA, ISO, and AATB requirements as applicable
Ability to communicate effectively both orally and in writing
Ability to multitask
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 Some experience with records maintenance and document control preferred

3. Managerial Experience
4. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications
Must be able to reason independently and work with 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.
5. Working Conditions
Working conditions include normal office environment, laboratory setting, environmentally controlled area (ECA), clean rooms, and other sterile environments
Standard hours are Monday - Friday; 8:00 am - 5:00 pm. Work may require occasional weekend/evening work
Work may require 4+ hours of continuous standing
Will safely operate machinery such as sealers, surgical instrumentation, and other laboratory equipment
May work in conditions leading to minor personal discomfort such as temperatures above or below personal comfort levels
Regular lifting and movement of materials and supplies, some of which are heavy
Operating a pallet jack with heavy loads and working around operating forklifts and trucks
Duties may include contact with human tissue, blood, bone, and fluids
6. Health and Safety
Must adhere to all health and safety requirements specified when entering laboratory and manufacturing areas and in the handling of company products
Must handle and store materials and supplies in a manner that is safe for employees and protects the items from damage
Will require experience or training in the routine handling of chemicals and biohazards
May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable

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.


Keywords: Xtant Medical Holdings Inc, Billings , Packaging & Labeling Associate, Other , Belgrade, Montana

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