Director of Quality Assurance jobs in United States
cer-icon
Apply on Employer Site
company-logo

ZEO ScientifiX · 13 hours ago

Director of Quality Assurance

ZEO ScientifiX is a clinical stage biotechnology company developing cell and extracellular vesicle-based therapeutics. They are seeking a Quality Assurance Director to oversee the Quality Management Program for the manufacturing and drug development laboratory.

BiotechnologyManufacturingMedicalTherapeutics

Responsibilities

Oversee the Quality Management Program for the manufacturing and drug development laboratory
Oversee and review facility operation practices
Quality control procedures
Inventory and material management
Electronic document control system
Maintenance of laboratory SOPs
Documentation audits
Manage the quality assurance and quality control team
Work jointly with the Laboratory Director to ensure facility compliance and maintain operational standards for cell and biologic manufacturing

Qualification

Biomedical quality systemsFDA regulatory requirementsCGMP regulationsBiomedical Sciences degreeComputer proficiencyProfessional etiquetteSelf-initiativeOrganizational skillsAttention to detailCommunication skillsWriting skills

Required

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
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
Bachelor of Science (BS) degree or Higher (required)

Benefits

401K Program
Health Insurance, Dental, Vision

Company

ZEO ScientifiX

twittertwittertwitter
company-logo
ZEO ScientifiX develops biological therapeutics for regenerative medicine, focusing on treatments for degenerative diseases.