Bio-Manufacturing Technician I - Processing

Status: 

Reports To: 

A.Purpose and Scope of Position

B.Organizational Relationship 

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 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
• Adhere to all Xtant Standard Operating Procedures (SOPs) and safety protocols while operating in compliance with regulatory standards
• Develop and maintain an understanding of Xtant products and general biological and chemical systems utilized within the Processing Department.  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
• Support the Xtant mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients
• 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
• Responsible for debriding, shaping, sizing, grinding, milling, demineralizing, labeling, and packaging of human tissue intended for transplantation
• Know the appropriate storage conditions, locations, and tissue handling methods for unprocessed and processed donor tissue
• Aseptically set up processing cleanroom, equipment, and supplies for use during processing and packaging procedures
• Inspect all processing reagents, supplies, instruments, and equipment prior to use to ensure acceptability for use in tissue processing
• Safely operate, monitor, and maintain processing instruments and equipment in accordance with manufacturer recommendations and equipment-specific SOPs when applicable
• 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
• Accurately assign and verify appropriate product codes and dimension/volume specifications
• Perform in-process Quality Control (QC) as required by Xtant SOPs and the Quality System
• Accurately enter appropriate donor and graft information into material tracking reports
• Assist in donor tissue and material movement
• Must maintain confidentiality of donor and recipient information
• Provide assistance and support to other teams, departments, team leads, and supervisors as requested

2.Financial Responsibilities

• Submit timely expense reports and abide by the Expense Reimbursement Policy

3.Training

• Responsible for participating in training plans and programs and completing assigned training in a timely manner within set deadlines
• Complete all required training prior to attempting to perform a task
• Maintain accurate and detailed training documentation. Ensure training is up to date
• Complete Document Read Training (DRT) within required deadlines whenever a document within the Quality System undergoes revision
• Upon hire, employee will rotate through processing support teams in order to learn various tasks associated with production and donor processing

4.Management

• This position does not supervise others

5.Document Control and Record Control

• Assist in the completion and retention of production-related and processing-related documents and records
• 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 current GDP and review the information of others as required
• Participate in the completion of Donor Processing Records as applicable
• Participate in changes to documents and to products and processes
• Maintain information in physical and electronic files as required
• Complete document corrections in a timely manner and maintain error rates at or below departmental benchmarks

6.Other duties as assigned

7.Performance of Duties

• Complete required training prior to performing tasks, including initial orientation and environmental health and safety training.  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

1.Education/Credentials Experience & Training

• High school diploma required
• Two-year degree or more in the Physical or Life Sciences, Healthcare, or Engineering is a plus or equivalent advanced training/certifications and experience
• Willing to acquire Certified Tissue Bank Specialist (CTBS) certification
• Knowledge of human anatomy preferred
• Knowledge and experience in biologics manufacturing or other relevant cleanroom/aseptic environments preferred, but not required 
• Familiarity with basic laboratory techniques, such as acid-base reactions, measuring and mixing reagents, and general laboratory equipment is desired

2.Technical Requirements/Skills

• Must be willing to acquire knowledge of FDA, ISO, and AATB regulations, as applicable
• Develop an understanding of aseptic techniques and practices
• Demonstrate capability to communicate effectively both orally and in writing
• Ability to multitask and manage time efficiently
• Ability to analyze information to draw relevant conclusions
• Must be able to adapt to quickly changing priorities and schedules
• Must possess excellent organizational skills and strong attention to detail
• Must be able to reason independently and work with minimal guidance
• Basic computer skills are required, such as knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
• Some experience with records maintenance and document control preferred

3.Managerial Experience

• N/A

4.Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications

• Ability to interpret data and make sound, independent judgments based on those interpretations
• 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
• Mechanical aptitude or an understanding of simple mechanical systems is advantageous
• Encourage development of a positive, productive work environment

5.Working Conditions

• Working conditions include normal office environment, environmentally controlled areas (ECAs), cleanrooms, and decontamination areas
• May require evening work and weekend work
• Shift times may vary depending on the needs of the department. Employee’s shift will be subject to change based on those needs
• Will operate precision cutting equipment and other various tissue processing machinery
• Must have excellent manual dexterity and good eye/hand/foot coordination
• May require 4+ hours of continuous standing
• Must be able to perform repetitive tasks/motions
• Must be able to record information legibly by hand
• Must be able to lift, push, and pull 60 lbs.

6. Health and Safety

• Duties will include direct contact with human tissue, blood, bone, and fluids
• Must adhere to all health and safety requirements specified when entering processing, device manufacturing, and decontamination areas and in the handling of company products
• 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
• Will require experience or training in the routine handling of chemicals and biohazards
• Will require OSHA blood borne pathogen training, SDS familiarity, and other safety training as applicable
• 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

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.

This position does not offer H-1B Visa Sponsorship.