Packaging & Labeling Associate
Company: Xtant Medical Holdings Inc
Location: Belgrade
Posted on: August 4, 2022
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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
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