Packaging & Labeling Associate

Company: Xtant Medical Holdings Inc
Location: Belgrade
Posted on: August 4, 2022

Job Description:

Status: Full Time - Non-ExemptReports To: Bio Operations ManagerA. Purpose and Scope of PositionThis 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 ResponsibilitiesSpecific Job Duties/ResponsibilitiesDevelop 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 practiceAdhere 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) StandardsDevelop 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 applicableSupport Xtant's mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patientsPerform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measuresRead, Review, and maintain an understanding of the company quality manual and know where it is locatedRepresent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employeesExecute day-to-day materials coordination to promote manufacturing operations and quality efficiencies and effective control in a Good Manufacturing Practices (GMP) regulatory environmentCoordinate 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 managementEnsure appropriate inventory levels are maintainedUnderstand Microsoft applications (Word, Excel, Access, Outlook, etc.) for minor reporting responsibilities and data entryClean, maintain and operate instruments and equipment as neededBe able to use equipment such as Industrial label printers and sealers. Common office equipment such as copy machines are also usedAssemble finished good products with designated labeling materials and print labels using barcode softwareMust be able to work in a fast-paced team environment producing maximum results to meet company goalsOperates FedEx shipment manager software to generate labels and documentsMaintain accurate records of all transactions and activitiesMaintain a variety of purchasing & inventory records and reportsCoordinate and organize scheduled inventory counts for assigned areasEnsure accurate and complete records are kept regarding material use, cost, stock levels, reorder points and other dataCoordinate disposal of biohazardous wasteMaintain dry ice inventoryReceive and inspect shipments and handle all receiving paperworkFinancial ResponsibilitiesSubmit timely expense reports and abide by the Expense Reimbursement PolicyTrainingParticipate in training plans and programs and complete in a timely manner within set deadlinesComplete required training prior to attempting to perform a taskMaintain required training documentationManagementThis position does not supervise othersWorks with and supports the activities of all departments as neededDocument Control and Record ControlAssist in the completion and retention of documentation pertaining to all SOPs as requiredLegibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as requiredWrite 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 assignedMaintain information in physical and electronic files as requiredTrain on and demonstrate proficiency in Xtant Medical's document control systemOther duties as assigned Performance of DutiesComplete required training, including initial orientation and environmental health and safety training, prior to performing tasks. Keep training up to datePerform all duties according to established procedures and follow appropriate safety precautions and measuresConduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end-usersMaintain a clean and safe working environment at all timesMust maintain the confidentiality of donor and recipient information according to HIPAAD. Job RequirementsEducation/Credentials Experience & TrainingHigh school diploma or equivalentOne (1) year prior experience with warehouse processes is preferredTechnical Requirements/SkillsSome knowledge of FDA, ISO, and AATB requirements as applicableAbility to communicate effectively both orally and in writingAbility to multitaskMust possess excellent organizational skills and strong attention to detailBasic computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessarySome experience with records maintenance and document control preferred3. Managerial ExperienceN/A4. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable QualificationsMust be able to reason independently and work with guidanceAbility to interpret data and make sound judgments based on those interpretationsMust deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poiseMust be able to adapt to quickly changing priorities and schedulesAbility to maintain good working relationships with all co-workers and the general public and use good judgment in recognizing scope and authorityMust have excellent manual dexterity and good eye/hand/foot coordinationMust be able to perform repetitive tasks/motionsMust be able to lift, push, and pull 60 lbs.5. Working ConditionsWorking conditions include normal office environment, laboratory setting, environmentally controlled area (ECA), clean rooms, and other sterile environmentsStandard hours are Monday - Friday; 8:00 am - 5:00 pm. Work may require occasional weekend/evening workWork may require 4+ hours of continuous standingWill safely operate machinery such as sealers, surgical instrumentation, and other laboratory equipmentMay work in conditions leading to minor personal discomfort such as temperatures above or below personal comfort levelsRegular lifting and movement of materials and supplies, some of which are heavyOperating a pallet jack with heavy loads and working around operating forklifts and trucksDuties may include contact with human tissue, blood, bone, and fluids6. Health and SafetyMust adhere to all health and safety requirements specified when entering laboratory and manufacturing areas and in the handling of company productsMust handle and store materials and supplies in a manner that is safe for employees and protects the items from damageWill require experience or training in the routine handling of chemicals and biohazardsMay 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. PI184789290SDL2017

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