Clean and maintain GMP facility, perform equipment maintenance, and manage supply inventory; maintain quality assurance practices in compliance with standard operating procedures (SOPs) and other applicable Federal, State, and local regulations. Resolve mechanical and technical issues relating to GMP facility and equipment. Perform all technical aspects associated with human islet cell processing, including setting up for islet isolation, all steps of the isolation process, and post-isolation cleanroom cleaning and QC test according to SOPs. Train and supervise new islet isolation team members and volunteers according to SOPs, record the training, and maintain their training records. Conduct annual competency training for existing team members. Essential Job Statements Clean and maintain the GMP facility and equipment, ensuring compliance with SOPs and regulatory requirements. Constantly recognize, monitor, and evaluate GMP facility and equipment's technical, instrumental, and physical conditions. Resolve and immediately report any issues or concerns. Manage supply inventory, send purchase requisitions for items requiring refill and services, and proactively communicate and follow up with internal buyers and external vendors. Receive delivered items according to SOP, quarantine them when necessary, and store them at appropriate storage. Set up the cleanroom and participate in islet isolation. Clean the reusable tools and the cleanroom after the isolation. Perform QC testing, handle microbiology samples, and report the results according to SOPs. Prepare and send a sterility cart to the Sterile Processing Department (SPD). Effectively communicate with SPD personnel for troubleshooting in a timely fashion. Restock lab supplies and autoclave items inventory, as necessary. Plan, perform, and supervise SOP training for new isolation team members. Plan and execute annual competency training for the existing team members. Maintain all team members' training records preparing for the FDA inspection. As needed, create new and revise existing SOPs consistent with current GMP and GTP guidelines. Work collaboratively with staff, interdisciplinary team members, personnel from other departments, and service/supply vendors in a fast-paced and changing environment. May perform molecular and immunologic procedures to conduct research using tissues and cells and assist with the department's goals where appropriate. Assume leadership role and responsibility to operate the GMP lab when needed. Patient Population Not applicable to this position. Employment Qualifications Required Education: Bachelor's Degree in Molecular Biology, Genetics, or a related field from an accredited program Preferred Education: Master's Degree or Ph.D. in Molecular Biology, Genetics, or a related field from an accredited program Licensure/Certification Required: N/A Licensure/Certification Preferred: N/A Minimum Qualifications Years and Type of Required Experience 3-5 years of laboratory experience in the field of molecular biology, genetics and/or immunology Other Knowledge, Skills and Abilities Required: Team-oriented with outstanding communication skills Multi-tasking and prioritization skills Have the basics of GMP/GTP principles, regulations, and guidelines. Cultural Responsiveness Other Knowledge, Skills and Abilities Preferred: Hands-on experience in human islet cell isolation and related-research Skilled in molecular techniques (Microarrays, RT-PCR, real-time PCR, RNA isolation, DNA isolation) Working Conditions Periods of high stress and fluctuating workloads may occur. May be exposed to human blood and other potentially infectious materials. * * Individuals in this position are required to exercise universal precautions, use personal protective equipment and devices, and learn the policies concerning infection control. Physical Requirements Physical Demands: Lifting/ Carrying (0-50 lbs.), Push/ Pull (0-50 lbs.), Stoop, Kneel, Squat Work Position: Additional Physical Requirements/ Hazards Physical Requirements: Manual dexterity (eye/hand coordination), Perform Shift Work, Hear alarms/telephone/tape recorder, Reach above shoulder, Repetitive arm/hand movements, Finger Dexterity, Color Vision, Acuity – near Hazards: Exposure to toxic/caustic/chemicals/detergents Mental/Sensory – Emotional Mental / Sensory: Strong Recall, Reasoning, Problem Solving, Hearing, Speak Clearly, Write Legibly, Reading, Logical Thinking Emotional: Fast pace environment, Steady Pace, Able to Handle Multiple Priorities, Frequent and Intense Customer Interactions, Noisy Environment, Able to Adapt to Frequent Change EEO Employer/Disabled/Protected Veteran/41 CFR 60-1.4. Who We Are Inventing better care, day by day by discovery Sound outrageous? It absolutely is. Sound impossible? That’s never stopped us before. Sound like hard work, intense research, collaboration with experts around the world, sheer brainpower meets unrelenting willpower? That’s. Exactly. Right. We’ll do whatever it takes to offer the best in care and empower the best in quality of life. And it’s an approach that works — whether it’s a patient who undergoes a new, life-saving procedure or a clinical researcher who finds promise in a new cancer treatment, exciting new medicine is happening at VCU Health. We have it all: • One college and four health sciences schools • An academic medical center • A Level I trauma center • One of only two NCI-designated cancer centers in Virginia • The region’s only full-service children’s hospital • More than 800 physicians in 200 specialties • With a community health center, dedicated research teams, facilities and valued partners in every field Our medical teams are top notch. And we’re not too shy to boast of internationally known physicians, some recognized as the best in the country, top-ranked local specialists and all-around all-stars at every level. From our very first years to our most recent advancements, we are driven to learn more, dig deeper, teach passionately and never rest in order to be a true leader in discovering what’s possible in health and recovery. We are a comprehensive system of care and a pioneer of health. Read VCU Health Year In Review for more about our accomplishments.