QA/QC Associate

Company Description

ZEO ScientifiX is a clinical stage biotechnology company developing cell and extracellular vesicle-based therapeutics. ZEO ScientifiX is seeking a Quality Assurance/Quality Control Associate to perform technical and quality procedures within our Quality Management Program for the manufacturing and drug development laboratory.

Responsibilities of the Quality Control Associate include a variety of technical activities involved with biologic drug manufacturing and quality assurance/control operations.

South Florida local applicants are encouraged to apply

Responsibilities:

• Manage quality control activities involved with biologic drug manufacturing and facility quality control operations.

• In general, oversee and review facility operation practices, complete and review product testing procedures, maintenance of laboratory SOPs, participate in process validations, and complete equipment management.

• Work jointly with the lab team to ensure facility compliance and maintain operational standards for cell and biologic manufacturing.

• Ensures compliance with regulatory standards (e.g., FDA, EMA, CLIA, GLP, GMP)

• Coordinate lab training and competency tracking

• Reviews validation and qualification documentation (equipment, methods, systems)

• Ensures data integrity and adherence to Good Documentation Practices (GDP)

• Perform environmental monitoring

Qualifications:

· Must have prior experience in a biomedical / tissue manufacturing quality systems operation

· 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

Job Type:

Full Time

Education:

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

Benefits:

401K Program

Health Insurance, Dental, Vision