Bio-Manufacturing Technician I - Processing

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    "requisitionDescription": "<div><div><p><span style=\"color: rgb(0, 0, 0);\"><strong>Status:&nbsp;</strong>Full Time, Non-exempt</span></p><p><span style=\"color: rgb(0, 0, 0);\"><strong>Reports To:&nbsp;</strong>Processing Team Lead</span></p><p><span style=\"color: rgb(0, 0, 0);\"><strong>A.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Purpose and Scope of Position</strong></span></p><p><span style=\"color: rgb(0, 0, 0);\">This position will perform activities related to donor tissue processing while maintaining quality and regulatory compliance within their department. &nbsp;This person does not supervise others and will support the activities of the Processing Team Lead(s) and Supervisors. &nbsp;This position interacts with employees in the Processing Department and may interact with other department supervisors, team leads, and personnel as necessary.</span></p><p><span style=\"color: rgb(0, 0, 0);\"><strong>B.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Organizational Relationship&nbsp;</strong></span></p><p><span style=\"color: rgb(0, 0, 0);\">This position reports to the Processing Team Lead or Supervisor. This position may provide additional support to other team leads, supervisors, or departments as requested.</span></p><p><span style=\"color: rgb(0, 0, 0);\"><strong>C.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Duties and Responsibilities</strong></span></p><p><span style=\"color: rgb(0, 0, 0);\"><strong>1.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Specific Job Duties/Responsibilities</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">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 for Standardization (ISO) 13485, European Medical Device Directives (MDD), Canadian Medical Device Regulations, Occupational Safety and Health Administration (OSHA), and other regulatory standards as applicable</span></li><li><span style=\"color: rgb(0, 0, 0);\">Adhere to all Xtant Standard Operating Procedures (SOPs) and safety protocols while operating in compliance with regulatory standards</span></li><li><span style=\"color: rgb(0, 0, 0);\">Develop and maintain an understanding of Xtant products and general biological and chemical systems utilized within the Processing Department. &nbsp;Know how the activities performed in the Processing Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable</span></li><li><span style=\"color: rgb(0, 0, 0);\">Support the Xtant mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients</span></li><li><span style=\"color: rgb(0, 0, 0);\">Maintain 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 SOPs</span></li><li><span style=\"color: rgb(0, 0, 0);\">Responsible for debriding, shaping, sizing, grinding, milling, demineralizing, labeling, and packaging of human tissue intended for transplantation</span></li><li><span style=\"color: rgb(0, 0, 0);\">Know the appropriate storage conditions, locations, and tissue handling methods for unprocessed and processed donor tissue</span></li><li><span style=\"color: rgb(0, 0, 0);\">Aseptically set up processing cleanroom, equipment, and supplies for use during processing and packaging procedures</span></li><li><span style=\"color: rgb(0, 0, 0);\">Inspect all processing reagents, supplies, instruments, and equipment prior to use to ensure acceptability for use in tissue processing</span></li><li><span style=\"color: rgb(0, 0, 0);\">Safely operate, monitor, and maintain processing instruments and equipment in accordance with manufacturer recommendations and equipment-specific SOPs when applicable</span></li><li><span style=\"color: rgb(0, 0, 0);\">Safely prepare and handle processing reagents and solutions according to SDS and SOPs and follow OSHA bloodborne pathogen standards, Universal Precautions, and current Good Tissue Practices (cGTP) when handling biological material</span></li><li><span style=\"color: rgb(0, 0, 0);\">Accurately assign and verify appropriate product codes and dimension/volume specifications</span></li><li><span style=\"color: rgb(0, 0, 0);\">Perform in-process Quality Control (QC) as required by Xtant SOPs and the Quality System</span></li><li><span style=\"color: rgb(0, 0, 0);\">Accurately enter appropriate donor and graft information into material tracking reports</span></li><li><span style=\"color: rgb(0, 0, 0);\">Assist in donor tissue and material movement</span></li><li><span style=\"color: rgb(0, 0, 0);\">Must maintain confidentiality of donor and recipient information</span></li><li><span style=\"color: rgb(0, 0, 0);\">Provide assistance and support to other teams, departments, team leads, and supervisors as requested</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>2.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Financial Responsibilities</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">Submit timely expense reports and abide by the Expense Reimbursement Policy</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>3.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Training</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">Responsible for participating in training plans and programs and completing assigned training in a timely manner within set deadlines</span></li><li><span style=\"color: rgb(0, 0, 0);\">Complete all required training prior to attempting to perform a task</span></li><li><span style=\"color: rgb(0, 0, 0);\">Maintain accurate and detailed training documentation. Ensure training is up to date</span></li><li><span style=\"color: rgb(0, 0, 0);\">Complete Document Read Training (DRT) within required deadlines whenever a document within the Quality System undergoes revision</span></li><li><span style=\"color: rgb(0, 0, 0);\">Upon hire, employee will rotate through processing support teams in order to learn various tasks associated with production and donor processing</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>4.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Management</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">This position does not supervise others</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>5.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Document Control and Record Control</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">Assist in the completion and retention of production-related and processing-related documents and records</span></li><li><span style=\"color: rgb(0, 0, 0);\">Assist in the completion and retention of documentation pertaining to all SOPs as required</span></li><li><span style=\"color: rgb(0, 0, 0);\">Legibly and accurately complete all documentation associated with assigned duties in accordance with current GDP and review the information of others as required</span></li><li><span style=\"color: rgb(0, 0, 0);\">Participate in the completion of Donor Processing Records as applicable</span></li><li><span style=\"color: rgb(0, 0, 0);\">Participate in changes to documents and to products and processes</span></li><li><span style=\"color: rgb(0, 0, 0);\">Maintain information in physical and electronic files as required</span></li><li><span style=\"color: rgb(0, 0, 0);\">Complete document corrections in a timely manner and maintain error rates at or below departmental benchmarks</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>6.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Other duties as assigned</strong></span></p><p><span style=\"color: rgb(0, 0, 0);\"><strong>7.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Performance of Duties</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">Complete required training prior to performing tasks, including initial orientation and environmental health and safety training. &nbsp;Keep training up to date</span></li><li><span style=\"color: rgb(0, 0, 0);\">Perform all duties according to established procedures and follow appropriate safety precautions and measures</span></li><li><span style=\"color: rgb(0, 0, 0);\">Conduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end users</span></li><li><span style=\"color: rgb(0, 0, 0);\">Maintain a clean and safe working environment at all times</span></li><li><span style=\"color: rgb(0, 0, 0);\">Must maintain confidentiality of donor and recipient information according to HIPAA</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>D.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Job Requirements</strong></span></p><p><span style=\"color: rgb(0, 0, 0);\"><strong>1.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Education/Credentials Experience &amp; Training</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">High school diploma required</span></li><li><span style=\"color: rgb(0, 0, 0);\">Two-year degree or more in the Physical or Life Sciences, Healthcare, or Engineering is a plus or equivalent advanced training/certifications and experience</span></li><li><span style=\"color: rgb(0, 0, 0);\">Willing to acquire Certified Tissue Bank Specialist (CTBS) certification</span></li><li><span style=\"color: rgb(0, 0, 0);\">Knowledge of human anatomy preferred</span></li><li><span style=\"color: rgb(0, 0, 0);\">Knowledge and experience in biologics manufacturing or other relevant cleanroom/aseptic environments preferred, but not required&nbsp;</span></li><li><span style=\"color: rgb(0, 0, 0);\">Familiarity with basic laboratory techniques, such as acid-base reactions, measuring and mixing reagents, and general laboratory equipment is desired</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>2.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Technical Requirements/Skills</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">Must be willing to acquire knowledge of FDA, ISO, and AATB regulations, as applicable</span></li><li><span style=\"color: rgb(0, 0, 0);\">Develop an understanding of aseptic techniques and practices</span></li><li><span style=\"color: rgb(0, 0, 0);\">Demonstrate capability to communicate effectively both orally and in writing</span></li><li><span style=\"color: rgb(0, 0, 0);\">Ability to multitask and manage time efficiently</span></li><li><span style=\"color: rgb(0, 0, 0);\">Ability to analyze information to draw relevant conclusions</span></li><li><span style=\"color: rgb(0, 0, 0);\">Must be able to adapt to quickly changing priorities and schedules</span></li><li><span style=\"color: rgb(0, 0, 0);\">Must possess excellent organizational skills and strong attention to detail</span></li><li><span style=\"color: rgb(0, 0, 0);\">Must be able to reason independently and work with minimal guidance</span></li><li><span style=\"color: rgb(0, 0, 0);\">Basic computer skills are required, such as knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary</span></li><li><span style=\"color: rgb(0, 0, 0);\">Some experience with records maintenance and document control preferred</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>3.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Managerial Experience</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">N/A</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>4.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">Ability to interpret data and make sound, independent judgments based on those interpretations</span></li><li><span style=\"color: rgb(0, 0, 0);\">Must be able to compose oneself in a professional and courteous manner in all aspects of interaction with fellow employees and use good judgment in recognizing scope and authority. Represent the company in a professional manner to the public, customers, and vendors and maintain trusting, respectful relationships with physician partners, customers, and fellow employees</span></li><li><span style=\"color: rgb(0, 0, 0);\">Mechanical aptitude or an understanding of simple mechanical systems is advantageous</span></li><li><span style=\"color: rgb(0, 0, 0);\">Encourage development of a positive, productive work environment</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>5.<span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Working Conditions</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">Working conditions include normal office environment, environmentally controlled areas (ECAs), cleanrooms, and decontamination areas</span></li><li><span style=\"color: rgb(0, 0, 0);\">May require evening work and weekend work</span></li><li><span style=\"color: rgb(0, 0, 0);\">Shift times may vary depending on the needs of the department. Employee&rsquo;s shift will be subject to change based on those needs</span></li><li><span style=\"color: rgb(0, 0, 0);\">Will operate precision cutting equipment and other various tissue processing machinery</span></li><li><span style=\"color: rgb(0, 0, 0);\">Must have excellent manual dexterity and good eye/hand/foot coordination</span></li><li><span style=\"color: rgb(0, 0, 0);\">May require 4+ hours of continuous standing</span></li><li><span style=\"color: rgb(0, 0, 0);\">Must be able to perform repetitive tasks/motions</span></li><li><span style=\"color: rgb(0, 0, 0);\">Must be able to record information legibly by hand</span></li><li><span style=\"color: rgb(0, 0, 0);\">Must be able to lift, push, and pull 60 lbs.</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>6. <span style=\"white-space:pre;\">&nbsp; &nbsp;&nbsp;</span>Health and Safety</strong></span></p><ul><li><span style=\"color: rgb(0, 0, 0);\">Duties will include direct contact with human tissue, blood, bone, and fluids</span></li><li><span style=\"color: rgb(0, 0, 0);\">Must adhere to all health and safety requirements specified when entering processing, device manufacturing, and decontamination areas and in the handling of company products</span></li><li><span style=\"color: rgb(0, 0, 0);\">This position will often be required to wear personal protective equipment (PPE), including but not limited to scrubs, laboratory coat, gloves, face shields, helmets, boot covers, and sterile suits</span></li><li><span style=\"color: rgb(0, 0, 0);\">Will require experience or training in the routine handling of chemicals and biohazards</span></li><li><span style=\"color: rgb(0, 0, 0);\">Will require OSHA blood borne pathogen training, SDS familiarity, and other safety training as applicable</span></li><li><span style=\"color: rgb(0, 0, 0);\">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</span></li></ul><p><span style=\"color: rgb(0, 0, 0);\"><strong>Note:</strong><span style=\"white-space:pre;\"><strong>&nbsp;&nbsp;</strong> &nbsp;</span>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.</span></p><p><span style=\"color: rgb(0, 0, 0);\"><strong>This position does not offer H-1B Visa Sponsorship.</strong><br></span></p><p><span style=\"color: rgb(0, 0, 0);\"><em>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.</em></span></p><p><br></p></div></div>\n<br/>Mon - Fri. 6 a.m. - 3 p.m.",
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