Xtant Medical Holdings, Inc. Packaging & Labeling Associate in Belgrade, Montana
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
1. 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
2. Financial Responsibilities • Submit timely expense reports and abide by the Expense Reimbursement Policy
3. 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
4. Management • This position does not supervise others • Works with and supports the activities of all departments as needed
5. 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
6. Other duties as assigned
7. 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 confidentiality of donor and recipient information according to HIPAA D. Job Requirements
8. Education/Credentials Experience & Training • High school diploma or equivalent • One (1) year prior experience with warehouse processes is preferred
9. 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
10. Managerial Experience • N/A
11. 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.
12. Working Conditions • Working conditions include normal office environment, laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments • Standard hours are Monday - Friday; 8:00am - 5:00pm. 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 work around operating forklifts and trucks • Duties may include contact with human tissue, blood, bone, and fluids
13. 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 (blood borne 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.