Quality Representative

About Andrews Research & Education Foundation

Andrews Research & Education Foundation (AREF) is seeking a motivated professional to join our research team as a Quality Representative supporting the Regenerative Medical Center. AREF is the research and education arm of the Andrews Institute. All efforts of AREF are under the leadership of internationally renowned orthopedic surgeon Dr. James Andrews. The goal of AREF’s research and educational initiatives are to provide the best evidence-based practices for injury prevention, injury treatment, return to play or work rehabilitation programs, and increased performance.

AREF’s programs provide service to a wide range of clientele including athletes at all levels, the general population, physicians, rehabilitation professionals, health providers, and wounded warriors.

AREF’s Regenerative Medicine Center (RMC) was designed and built to pioneer the translation of regenerative medicine treatments from early clinical and animal studies to evidence patient care. RMC includes clinical space for regenerative medicine procedures and a facility for GMP/GTP compliant tissue processing and storage for developing stem cell technologies. The tissue processing and storage facility includes a classified ISO 7 clean room, cryopreservation equipment, and flow cytometry.

• Compliance and Quality System Management:
  Maintain the organizational structure, responsibilities, policies, processes, procedures, and resources established to achieve quality.
• Documentation, Record Retention, and Auditing:
  Oversee documentation processes to ensure that a record is maintained for all activities; plan and conduct internal audits and assessments, gathering objective evidence to demonstrate compliance.
• Management and Improvement:
  Assist executive management in the review of the quality system and compliance with specified requirements; develop and monitor risk assessment and mitigation strategies.

This is a salaried/exempt position eligible for benefits. This position is not eligible for visa sponsorship or visa transfer. This position is subject to pre-employment background and drug screening. Employment offers are contingent upon satisfactory results.

Laboratory Director

Salaried Exempt

• Maintain and develop a Quality Management System (QMS) to establish RMC’s processes, procedures, and responsibilities for achieving quality policies, practices, and objectives to ensure quality is infused into every patient or donor process.
• Ensure all cellular therapy activities comply with applicable laws and regulations, including all current good manufacturing practice (cGMP) requirements.
• Review, write, and revise policies, processes, and procedures to ensure they are simple, clear, and practical.
• Manage the process for documenting and approving exceptions to policies and procedures.
• Identify, investigate, and manage nonconformances identified during assessments.
• Help maintain and test the emergency operation and disaster continuity plans.
• Collaborate with the facility to ensure the quality and safety of procurement, processing, storage, distribution and administration of cellular therapy products.
• Follow all laws and regulations regarding human subject research.
• Assist the RMC Clinical Research Coordinator as needed in daily duties.
• Adhere to the essential functions of Andrews Research and Education Foundation’s Standard of Performance and Code of Conduct.
• Perform other duties as assigned to support the essential functions of the job and operational needs of the department and AREF.

The person in this position may be subject to over 40 hours per week. This is a Monday-Friday (daytime) position and may be subject to occasional weekend hours.

Summary of required and preferred education, experience, knowledge skills and abilities.

• Bachelor’s degree in a relevant scientific or health-related field (Medical technology, Biology, Quality Assurance).
• 2 years of experience in a regulated environment (cellular therapy, blood banking, clinical laboratory), with 1 year in a quality assurance or compliance role.
• Knowledge of regulatory policies and procedures related to cGCP, cGMP, and/or cGTP, and the AABB Standards for Cellular Therapy Services.
• Must be able to work in a collaborative, team environment.

• Any relevant education, certifications, and/or work experience in the following settings may be considered: regenerative medicine lab, tissue processing facility, testing laboratory, pharmacy clean room, or pharmaceutical manufacturing facility.
• Experience in writing standard operating procedures and quality management.
• Excellent verbal and written communication.
• Strong organization, time management, problem solving and critical thinking skills.
• Familiarity with research and data collection.
• Highly self-motivated with the ability to work independently and as part of a team.