Qualigen, Inc. (qualigeninc.com) develops, manufactures, and distributes the patented FastPack System which is the first blood testing system custom designed to perform quantitative immunoassay tests in the physician’s office laboratory. The FastPack System includes tests for prostate cancer, thyroid disorders, and male aging disorders, and is being expanded to cover a wide variety of blood tests.

Position Reports To: Lab Manager

Position Summary: Responsible for the formulation of kit components including bulk reagents according to written manufacturing instructions.  

Responsibilities:

•Responsible for all aspects of reagent formulations including:

oFormulation and preparation of buffers, diluents, enzyme conjugations to proteins, biotinylation, calibrator/control preparation and other solutions

oEvaluation of raw materials and in process testing

oPreparation of jobs based on the production schedule and initiating work orders 

oCompleting batch record documents and generating NCMRs and deviation reports as needed

oMaintaining lab equipment, wash glassware, and keep lab area clean

oChemical inventory maintenance and perform raw materials cycle counts

oOrder lab supplies and ensure any materials and equipment are available and in working order to complete jobs

•Additional responsibilities include but are not limited to:

oFilling and labeling operations

oIn-process inspections and testing

oMay support troubleshooting, investigation, and/or QC/R&D efforts 

Preferred Skills:

Education:B.S. degree in life sciences or chemistry

Experience:2+ years experience in reagent manufacturing under FDA / GMP regulations.

•Good working knowledge of chemistry/biochemistry and basic mathematics

•Good laboratory skills including laboratory safety, equipment operation and maintenance

•Good understanding of FDA regulations and GMP compliance

•Excellent documentation skills