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Lab Technician I

Preparation of reagents for biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.

 

Can work independently on reagent preparation that he/she has mastered in a safe and compliant manner.

 

Responsible for washing and stocking laboratory glassware used for analytical assays.

 

Maintains laboratory supply inventories and receives chemicals/materials into the laboratory.

 

Maintains the laboratory in an inspection-ready state. Ensures reagents in the laboratory are within expiry.

 

Provides support for routine laboratory functions/chores for the QC laboratory such as monitoring temperature charts, cleaning water baths and/or laboratory refrigerators/freezers/ storage cabinets where reagents are held.

 

Assists in the revision of written procedures as assigned regarding reagents and/or reagent management.

 

Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.

 

May interact with other departments, including but not limited to Manufacturing, Microbiology, Analytical Chemistry, Formulation, and Process Development. 

QC technician will perform reagent preparation and a variety of laboratory chores so that the effort of other personnel can be applied to assays for commercial and clinical products for release and stability testing.

 

At least one year in a cGMP/GLP laboratory; quality control experience is preferred.

 

Ability to follow written instructions and to perform tasks with direct or minimal supervision.

 

Familiarity with use of a computer; e.g., Proficient in Windows, Microsoft Word, Excel.

 

Good written, verbal, and communication skills.

 

Good documentation skills.

 

Demonstrates the ability to work independently, is motivated, and organized.

The QC technician should have an Associate Degree or should be working towards a degree. One year of laboratory experience is desired.

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