Director of Quality Assurance (Fort Lauderdale)
ZEO ScientifiX, Fort Lauderdale, Florida, United States, 33336
ZEO ScientifiX is looking for a Director of Quality Assurance
ZEO ScientifiX is a clinical stage biotechnology company developing cell and extracellular vesicle-based therapeutics. ZEO ScientifiX is seeking a Quality Assurance Director to oversee the Quality Management Program for the manufacturing and drug development laboratory.
Responsibilities of the Quality Assurance Director include a variety of management activities involved with biologic drug manufacturing and quality assurance/control operations. This Quality Assurance Director will oversee and review facility operation practices, quality control procedures, inventory and material management, electronic document control system, maintenance of laboratory SOPs, documentation audits, and other Quality Management/Compliance operations. This person will manage the quality assurance and quality control team. Will work jointly with the Laboratory Director to ensure facility compliance and maintain operational standards for cell and biologic manufacturing.
Qualifications: ·
Must have prior experience in a biomedical / tissue manufacturing quality systems operation ·
Must have prior experience in FDA regulatory requirements for biologic and HCT/P manufacturing practices. ·
Must have prior experience with cGMP regulations. ·
B.S. or M.S. in Biomedical Sciences or related sciences are encouraged to apply ·
Requirement of 5+ years of Quality Assurance experience in Biomedical Manufacturing
Must be highly motivated with professional etiquette Must be a skilled writer Must demonstrate self-initiative Have excellent organizational skills Have strong attention to detail Strong communication skills with internal and external individuals Must be comfortable working with computers and digital communication
Job Type: Full Time
Education: Bachelor of Science (BS) degree or Higher (required)
Benefits: 401K Program Health Insurance, Dental, Vision
ZEO ScientifiX is a clinical stage biotechnology company developing cell and extracellular vesicle-based therapeutics. ZEO ScientifiX is seeking a Quality Assurance Director to oversee the Quality Management Program for the manufacturing and drug development laboratory.
Responsibilities of the Quality Assurance Director include a variety of management activities involved with biologic drug manufacturing and quality assurance/control operations. This Quality Assurance Director will oversee and review facility operation practices, quality control procedures, inventory and material management, electronic document control system, maintenance of laboratory SOPs, documentation audits, and other Quality Management/Compliance operations. This person will manage the quality assurance and quality control team. Will work jointly with the Laboratory Director to ensure facility compliance and maintain operational standards for cell and biologic manufacturing.
Qualifications: ·
Must have prior experience in a biomedical / tissue manufacturing quality systems operation ·
Must have prior experience in FDA regulatory requirements for biologic and HCT/P manufacturing practices. ·
Must have prior experience with cGMP regulations. ·
B.S. or M.S. in Biomedical Sciences or related sciences are encouraged to apply ·
Requirement of 5+ years of Quality Assurance experience in Biomedical Manufacturing
Must be highly motivated with professional etiquette Must be a skilled writer Must demonstrate self-initiative Have excellent organizational skills Have strong attention to detail Strong communication skills with internal and external individuals Must be comfortable working with computers and digital communication
Job Type: Full Time
Education: Bachelor of Science (BS) degree or Higher (required)
Benefits: 401K Program Health Insurance, Dental, Vision