Status:
Full Time – Non-Exempt
Reports To:
Senior Buyer/Planner
A. Purpose and Scope of 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.
B. Organizational Relationship
This position reports to the Senior Buyer/Planner. This position may provide additional support to other team leads, supervisors, or departments as requested.
C. Duties and Responsibilities
Specific 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 Directive (MDD) and Canadian Medical Device and Tissue Regulations, as applicable, and adhere to standards and regulationsAdhere 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 regulationsDevelop 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 applicableSupport Xtant Medical’s mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patientsRead, Review, and maintain an understanding of the company quality manual and know where it is locatedPerform all duties according to Xtant Medical SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measuresComplete annual SOP review and OSHA safety trainingMaintain 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 SOPsFollow 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 cleaningClean, maintain, and operate instruments and equipment as neededCreate and process work orders based on current inventory usage to maintain an acceptable inventory level of irradiated supply packsDetermine and maintain raw supply inventory levels based on current and past production needs and be able to communicate needed supplies with the Materials departmentBe able to calculate needed quantities based on current inventory usageExecute day-to-day materials coordination to promote manufacturing operations and quality efficiencies and effective control in a Good Manufacturing Practices (GMP) regulatory environmentCoordinate disposal of biohazardous wastePerform receiving activities, including receiving, inspecting shipments and handle all receiving paperworkEnsure proper care and storage of all supplies per the Material SpecificationsMaintain awareness of expirations in order to effectively manage FIFO to minimize wasteResponsible for projects and assignments as requested by managementPerform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures Use and maintain ERP dataPerform Quality Control (QC) functions of examining and inspecting supplies to ensure the configuration is correct and undamaged following the SOPsPossess the skill to be accurate in stocking inventory to their designated places and perform proper inspections to ensure they are undamagedUnderstand Microsoft applications (Word, Excel, Access, Outlook, etc.) for minor reporting responsibilitiesBe able to use equipment such as sealers and weight scales. Common office equipment such as copy machines are also usedMust be able to work independently with minimal guidance producing maximum results to meet company goalsFinancial 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 taskPossess a willingness to train team members as needed on departmental processesMaintain required training documentationManagementThis position does not supervise othersMay sometimes direct the activities of staff to accomplish quality and company objectives as assignedWork with and support the activities of the department team lead(s), manager, and other divisions as requestedDocument Control and Record ControlAssist in the completion and retention of documentation pertaining to all SOPs (Standard Operating Procedures) as requiredWrite and revise a variety of technical documents including SOPs, quality standards and specifications, training documents, and inspection and testing protocols as needed and assignedLegibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as requiredParticipate in the completion of Device History Records (DHR) or Donor Processing Records as applicableParticipate in changes to documents and processes as requestedMaintain information in physical and electronic files as requiredTrain on and demonstrate proficiency in Xtant Medical’s document control systemOther duties as assignedPerformance of DutiesComplete required training prior to performing tasks, including initial orientation and environmental health and safety training. 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 customersMaintain a clean and safe working environment at all timesMust maintain confidentiality of donor and recipient informationMust maintain confidentiality of donor and recipient information according to HIPAAD. Job Requirements
Education/Credentials Experience & TrainingHigh School Diploma or equivalent. Two to four years college preferredExperience with company SOP’s document control or regulated environment preferredPrior experience with document and record retention is preferredTechnical Requirements/SkillsSome 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
- 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 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.
5. Working Conditions
- Working conditions include normal office environment, warehouse, laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
- 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 laboratory equipment
- May work in conditions leading to minor personal discomfort such as temperatures above or below personal comfort levels
- 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 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
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.
