Job Description
Job Overview:
Status: Full Time, Exempt
Reports To: Director of Laboratory Operations
A. Job Summary
This position is responsible for a variety of laboratory testing, microbial analysis, research, maintenance and supporting Xtant’s biologics manufacturing.
Key responsibilities include receiving, testing, and analyzing various biological and environmental samples; recording and reporting results; organizing laboratory logs; ordering and storing laboratory supplies; and calibration, maintenance and troubleshooting of equipment.
This position will also perform quality control tests/checks and review/audit reports when needed to ensure proper procedures.
B. Supervisory Responsibilities
- This position does not supervise individuals or teams.
C. Duties and Responsibilities
- Develop and maintain an understanding of relevant industry standards and regulations including but not limited to 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485, ensuring compliance with these requirements across the organization
- Adhere 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 OSHA Standards
- Adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products
- Collect, receive, label, and/or analyze biological and environmental samples.
- Record all observations, test results and data accurately and in the specified format (written and/or electronic)
- Clean, maintain, calibrate and troubleshoot laboratory equipment
- Maintain daily logs and equipment record
- Order laboratory supplies and perform receiving inspections as needed
- Document and evaluate quality control specimens to determine the acceptability of sample results
- Organize and store all chemical substances, fluids, and compressed gases according to safety instructions
- Ensure that all safety guidelines are always adhered to within the laboratory
- Develop and maintain an understanding of Xtant products and general biological systems. Know how the activities performed in the laboratory are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
- Actively contribute to the fulfillment of Xtant Medical’s mission, values, and quality policy
- Help with design and validation of laboratory tests
- Provide technical support to other departments, when necessary
- Keep up to date with relevant scientific and technical developments
- Other duties as assigned
D. Financial Responsibilities
- Submit timely expense reports and abide by the Expense Reimbursement Policy
E. Training
- Complete required training, including, but not limited to initial orientation and environmental health and safety training prior to performing tasks
- Participate in training programs, ensuring timely completion and accurate, up-to-date training records
- Complete annual SOP review and safety training (i.e. OSHA, blood borne pathogens) as applicable
- May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
- Will require experience or training in the routine handling of chemicals and biohazards
F. Document Control and Record Control
- 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 Good Documentation Practices (GDP) and review the written documentation of others as required
- Maintain information in physical and electronic files as required
- Train on and demonstrate proficiency in Xtant Medical’s document control system
- Write, review, and revise a variety of technical documents including SOPs, Test Protocols, and Work Instructions as needed
G. Performance of Duties
- Complete required training, including, but not limited to initial orientation and environmental health and safety training prior to performing tasks
- Participate in training programs, ensuring timely completion and accurate, up-to-date training records
- Complete annual SOP review and safety training (i.e. OSHA, blood borne pathogens) as applicable
- May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
- Will require experience or training in the routine handling of chemicals and biohazards
H. Technical Requirements/Skills
- Basic knowledge of MS Office Suite and database systems.
- Must understand and know how to use manual and automated equipment necessary for the testing and analysis of samples
- Must have a working knowledge of basic microbiology and associated testing
- Ability to write correspondence and reports
- Analytical and numerical skills: ability to perform mathematical calculations in different units of measurement; ability to use concepts such as fractions, percentages, ratios, and dilutions
I. Special Requirements, Physical Capabilities, and Abilities
- Superb dexterity and hand-eye coordination
- Strong organizational skills
- Have normal color vision and possess a good sense of smell
- Excellent verbal and written communication skills
- Ability to follow instructions and strictly follow procedures
- Ability to work autonomously and under pressure
- Strong analytical and critical thinking skills
- Strong attention to detail
J. Education, Training, and Experience
- Bachelor’s degree in microbiology, chemistry, or a related field is required
- One (1) to two (2) years’ experience working in a laboratory as a lab technician
- Experience operating electrical and non-electrical laboratory equipment
- Comfortable handling potentially dangerous substances (flammable liquids, blood and tissues, biohazards, etc.)
K. Working Conditions
- Working conditions will include a laboratory setting, environmentally controlled area (ECA), and other sterile environments.
- This position will require the use of personal protective equipment (PPE), including laboratory coat, scrubs, gloves, etc.
- Standard business hours are Monday – Friday; 8:00 am – 5:00 pm, with occasional evening or weekend work based on project needs
- Work will require long periods of sitting, standing, and working at a computer
- Duties will include contact with human tissue, blood, bone, and fluids and working in PPE
- Working in cleanroom suites with a face shield and masks as necessary
L. Physical Requirements
- Ability to sit, stand, and work at a computer for prolonged periods
- Ability to lift, carry, push or pull items of varying weight, typically up to 50 lbs
- Ability to move, bend, or twist the body in various ways
- Ability to perform repetitive motions, such as reaching, grasping, bending, squatting, and stooping
- Requires hand-eye coordination and manual dexterity for tasks such as typing, using hand tools or equipment, and assembling or handling small components with precision
- Ability to see clearly, whether with or without corrective lenses
- Ability to hear and understand safety signals, alarms, and customer requests in a noisy environment
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.
